Import Alert 99-34

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 99-34
Published Date: 02/05/2021
Type: DWPE

Import Alert Name:

DETENTION WITHOUT PHYSICAL EXAMINATION OF DRUGS OR MEDICAL DEVICES FROM FIRMS WITHOUT A VALID DRUG OR MEDICAL DEVICE REGISTRATION

Reason for Alert:

NOTE: The revisions to this import alert dated 10/20/2014 updates the CDRH Import Branch name and contact information, updates contact information for the Office of Regulatory Science and provides additional information on the removal process. Changes are bracketed by asterisks (***).

Complete, accurate, and up-to-date registration and listing information is critical for FDA to achieve its mission to minimize the risk and exposure of the United States public to unsafe and ineffective drugs and medical devices. The registration and listing data is used for inspections, recalls, drug and medical device shortages, drug and medical device quality reports, and adverse event reports, just to name a few relevant FDA uses of the data. If registration and listing data are inaccurate or missing altogether, FDA may simply be unaware of medical product supply chains, including firms, persons, manufacturers, and products that fall under its regulatory umbrella.

According to FDA regulations, an owner or operator of an establishment entering into, or currently engaged in medical activities/operations defined in

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/default.htm

and

http://www.fda.gov/Drugs/InformationOnDrugs/ucm135778.htm

must register and provide product listing data to show the relationship between the product and the establishment. This obligation must be met prior to distribution in the United States (U.S.). Given the increasingly global supply chain for drugs and medical devices, accurate data relevant to all medical establishments (foreign and domestic) and associated products placed in U.S. commerce is critical to ensure that products entering the country meet the United States standards for quality, safety, and effectiveness.

Offering an article that is a drug or medical device for import without establishment registration and drug or medical device listing is illegal under the Food, Drug, and Cosmetic Act ("Act"). Under section 510(i)(1) of the Act (21 U.S.C. 360(i)(1)), registration is required for each foreign establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing ("manufacture") of a drug or a medical device that is imported or offered for import into the United States at the time that the establishment begins that activity and during the period beginning October 1 and ending on December 31 of each year thereafter. Under sections 510(i)(2) and 510(j) of the Act (21 U.S.C. 360(i)(2) and 360(j)), registrants are required to report, among other information, a list of each drug and/or medical device they manufacture for commercial distribution, and to provide updates to that list (if any) at the time of annual registration and in June and December of each year for drugs, and between October 1 and December 31 for devices each year. The registration and listing requirements apply to all shipments of drugs, including drug substances and drugs in bulk packages, e.g. active pharmaceutical ingredients (APIs) for manufacturing finished dosage form products and APIs for compounding purposes.

Under section 502(o) of the Act (21 U.S.C. 352(o)), the failure to list a drug or medical device as required under section 510(j) or to supply certain notice or information about the drug or medical device required under section 510 renders a drug or medical device misbranded. In addition, the Food and Drug Administration Safety and Innovation Act (FDASIA), amended the Food, Drug, and Cosmetic to make clear that drugs and medical devices made at unregistered foreign firms are misbranded under section 502(o).

Section 801(a)(3) of the Act (21 U.S.C. 381(a)(3)) provides that drugs or medical devices that appear to be misbranded are subject to refusal of admission.

These requirements apply to all establishments that are required to register and all drugs or medical devices required to be listed that are imported or offered for import.

The Red List of this Import Alert identifies certain firms who are not registered or have inadequate registration and have imported or offered for import drugs or medical devices when they were not registered and their products listed. The establishments identified below were notified, by Warning Letter and/or other means, that they are in violation of the Act and their articles are subject to imports refusal as misbranded. These firms have not corrected the violations.

Guidance:

Districts may detain, without physical examination, the indicated products from the firms identified on the Red List of this import alert.

In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner or consignee should provide evidence indicating the subject firm has registered with FDA.

In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation.

For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be reviewed by DIO and then referred to CDER or CDRH for additional evaluation.

For questions or issues involving import operations, contact the Division of Import Operations at (301) 796-0356, or email fdaimportsinquiry@fda.hhs.gov.

*** Questions concerning drug registration can be directed to EDRLS@FDA.HHS.GOV or cderimportsexports@fda.hhs.gov, 301-796-3130, and

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm254946.htm

or

Questions concerning device registration can be directed to the CDRH/OC Imports Branch, reglist@cdrh.fda.gov or cdrhocimport@fda.hhs.gov, 301-796-5500, and

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/default.htm

If districts encounter devices from unregistered facilities please contact CDRH at (301) 796-7400, Option 2 or device.reg@fda.hhs.gov.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301-796-6600.

For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)." ***

Product Description:

All medical devices

Charge:

"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&CA It appears that the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by 510(j) or 510(k). "[Misbranding, Section 502(o), 801(a)(3)]"
OASIS charge code - NOT LISTED

and

"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&CA It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510 of the Act. "[Misbranding, Section 502(o), 801(a)(3)]"
OASIS charge code - FRNMFGREG

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


CHINA


CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd
Date Published : 03/29/2013
No. 188 Gongnong Road , Shijiazhuang, Hebei CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/29/2013

Notes: All Drugs

56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/29/2013

Desc: Antibiotics

60 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

61 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

62 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

63 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

64 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

65 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

66 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

Changzhou Jialing Medicine Industry Co. Ltd.
Date Published : 03/29/2013
Shui Bei Town Jin Tan City , Jiangsu, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/29/2013

Notes: All Drugs

56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/29/2013

Desc: Antibiotics

60 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

61 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

62 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

63 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

64 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

65 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

66 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

Changzhou Wujin Zhengping Shuangma Chemical Plant
Date Published : 03/29/2013
Qianhuang Town , Changzhou Jiangsu, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/29/2013

Notes: All Drugs

56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/29/2013

Desc: Antibiotics

60 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

61 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

62 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

63 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

64 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

65 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

66 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

Guangzhou Jimy Facial
Date Published : 02/03/2015
64 Hengzhigang Rd , Guangzhou, CHINA
73 - - - -- Anesthesiology
Date Published: 02/03/2015

74 - - - -- Cardiovascular
Date Published: 02/03/2015

76 - - - -- Dental
Date Published: 02/03/2015

77 - - - -- Ear,Nose And Throat
Date Published: 02/03/2015

78 - - - -- Gastroenterological & Urological
Date Published: 02/03/2015

79 - - - -- General & Plastic Surgery
Date Published: 02/03/2015

80 - - - -- General Hospital/Personal Use
Date Published: 02/03/2015

84 - - - -- Neurological
Date Published: 02/03/2015

85 - - - -- Obstetrical & Gynecological
Date Published: 02/03/2015

86 - - - -- Ophthalmic
Date Published: 02/03/2015

87 - - - -- Orthopedic
Date Published: 02/03/2015

89 - - - -- Physical Medicine
Date Published: 02/03/2015

90 - - - -- Radiological
Date Published: 02/03/2015

Shanghai Kindmax Sports Products Co.,Ltd
Date Published : 10/17/2014
Floor 3, No. 516 Wenchuan Road , Baoshan District , Shanghai, Shanghai CHINA
73 - - - -- Anesthesiology
Date Published: 10/17/2014

74 - - - -- Cardiovascular
Date Published: 10/17/2014

76 - - - -- Dental
Date Published: 10/17/2014

77 - - - -- Ear,Nose And Throat
Date Published: 10/17/2014

78 - - - -- Gastroenterological & Urological
Date Published: 10/17/2014

79 - - - -- General & Plastic Surgery
Date Published: 10/17/2014

80 - - - -- General Hospital/Personal Use
Date Published: 10/17/2014

84 - - - -- Neurological
Date Published: 10/17/2014

85 - - - -- Obstetrical & Gynecological
Date Published: 10/17/2014

86 - - - -- Ophthalmic
Date Published: 10/17/2014

87 - - - -- Orthopedic
Date Published: 10/17/2014

89 - - - -- Physical Medicine
Date Published: 10/17/2014

90 - - - -- Radiological
Date Published: 10/17/2014

Shenzhen Sibo Indl
Date Published : 05/04/2015
3a/F Bldg 27 Anle Indl Park Guankou No.2 , Shenzhen, CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 05/04/2015

Desc: Hand Held Electric Massager

Sunny Optoelectronic Tech Co.Ltd
Date Published : 02/19/2015
F 2 , No 14 Jia Luo Highway; Jiading , Shanghai, Shanghai CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 02/19/2015

Desc: Diode Laser Beauty Machine

Zhejiang Xianju Chemical Pharmaceutical Factory
Date Published : 03/29/2013
NO. 107 Hebu Drive , Chenguan , Xianju, Zhejiang CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/29/2013

Notes: All Drugs

56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/29/2013

Desc: Antibiotics

60 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

61 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

62 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

63 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

64 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

65 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

66 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs


HONG KONG SAR


GREEN ISLAND INTERNATIONAL TCM GROUP LIMITED
Date Published : 08/08/2014
7/F , Kiu Kin Mansion; 566-568 Nathan Road , Yau Ma Tei, Kowloon HONG KONG SAR
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 08/08/2014

Desc: Acu-Cupping Therapeutic Device; TENS device
Notes: Class 2 Medical Device

Peking Medicine Manufactory
Date Published : 03/29/2013
Unit B, 7/F, Phase 1 , Leader Industry Centre , Tsuen Wan, New Territories HONG KONG SAR
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/29/2013

Notes: All Drugs

56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/29/2013

Desc: Antibiotics

60 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

61 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

62 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

63 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

64 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

65 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

66 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs


INDIA


BIOLINE INDIA
Date Published : 08/21/2018
84 Electronics , Indore, INDIA
73 - - - -- Anesthesiology
Date Published: 08/21/2018

Notes: All Devices

74 - - - -- Cardiovascular
Date Published: 08/21/2018

Notes: All Devices

76 - - - -- Dental
Date Published: 08/21/2018

Notes: All Devices

77 - - - -- Ear,Nose And Throat
Date Published: 08/21/2018

Notes: All Devices

78 - - - -- Gastroenterological & Urological
Date Published: 08/21/2018

Notes: All Devices

79 - - - -- General & Plastic Surgery
Date Published: 08/21/2018

Notes: All Devices

80 - - - -- General Hospital/Personal Use
Date Published: 08/21/2018

Notes: All Devices

84 - - - -- Neurological
Date Published: 08/21/2018

Notes: All Devices

85 - - - -- Obstetrical & Gynecological
Date Published: 08/21/2018

Notes: All Devices

86 - - - -- Ophthalmic
Date Published: 08/21/2018

Notes: All Devices

87 - - - -- Orthopedic
Date Published: 08/21/2018

Notes: All Devices

89 - - - -- Physical Medicine
Date Published: 08/21/2018

Notes: All Devices

90 - - - -- Radiological
Date Published: 08/21/2018

Notes: All Devices

HD Medical Services (India) Private Limited
Date Published : 02/02/2015
#11 East Coast Road, Kanathur , Chennai, Tamil Nadu INDIA
73 - - - -- Anesthesiology
Date Published: 02/02/2015

Notes: All devices

74 - - - -- Cardiovascular
Date Published: 02/02/2015

Notes: All devices

76 - - - -- Dental
Date Published: 02/02/2015

Notes: All devices

77 - - - -- Ear,Nose And Throat
Date Published: 02/02/2015

Notes: All devices

78 - - - -- Gastroenterological & Urological
Date Published: 02/02/2015

Notes: All devices

79 - - - -- General & Plastic Surgery
Date Published: 02/02/2015

Notes: All devices

80 - - - -- General Hospital/Personal Use
Date Published: 02/02/2015

Notes: All devices

84 - - - -- Neurological
Date Published: 02/02/2015

Notes: All devices

85 - - - -- Obstetrical & Gynecological
Date Published: 02/02/2015

Notes: All devices

86 - - - -- Ophthalmic
Date Published: 02/02/2015

Notes: All devices

87 - - - -- Orthopedic
Date Published: 02/02/2015

Notes: All devices

89 - - - -- Physical Medicine
Date Published: 02/02/2015

Notes: All devices

90 - - - -- Radiological
Date Published: 02/02/2015

Notes: All devices

Sewa Medicals Ltd
Date Published : 05/28/2014
Gut No. 229-232, Alandi Markal Road , Village Markal Taluka Khed, Taluka:Khed , Pune, Maharashtra INDIA
73 - - - -- Anesthesiology
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

74 - - - -- Cardiovascular
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

76 - - - -- Dental
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

77 - - - -- Ear,Nose And Throat
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

78 - - - -- Gastroenterological & Urological
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

79 - - - -- General & Plastic Surgery
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

80 - - - -- General Hospital/Personal Use
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

84 - - - -- Neurological
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

85 - - - -- Obstetrical & Gynecological
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

86 - - - -- Ophthalmic
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

87 - - - -- Orthopedic
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

89 - - - -- Physical Medicine
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

90 - - - -- Radiological
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

94 - - - -- Ionizing Non-Medical Devices and Components
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

95 - - - -- Light Emitting Non-Device Products
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

96 - - - -- Radio Frequency Emitting Products
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

97 - - - -- Sound Emitting Products
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

TOP SYRINGE MFG CO
Date Published : 05/28/2014
317 - 21 Prospect Chambers Annexe , Dr D N Road , Mumbai, Maharashtra INDIA
73 - - - -- Anesthesiology
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

74 - - - -- Cardiovascular
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

76 - - - -- Dental
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

77 - - - -- Ear,Nose And Throat
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

78 - - - -- Gastroenterological & Urological
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

79 - - - -- General & Plastic Surgery
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

80 - - - -- General Hospital/Personal Use
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

84 - - - -- Neurological
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

85 - - - -- Obstetrical & Gynecological
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

86 - - - -- Ophthalmic
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

87 - - - -- Orthopedic
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

89 - - - -- Physical Medicine
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

90 - - - -- Radiological
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

94 - - - -- Ionizing Non-Medical Devices and Components
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

95 - - - -- Light Emitting Non-Device Products
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

96 - - - -- Radio Frequency Emitting Products
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)

97 - - - -- Sound Emitting Products
Date Published: 05/28/2014

Notes: Manufacturer (Medical Devices)


ITALY


Vupiesse Italia Srl
Date Published : 01/27/2015
49 Via Della Lontra , Rimini, Rimini ITALY
73 - - - -- Anesthesiology
Date Published: 01/27/2015

Notes: All devices

74 - - - -- Cardiovascular
Date Published: 01/27/2015

Notes: All devices

76 - - - -- Dental
Date Published: 01/27/2015

Notes: All devices

77 - - - -- Ear,Nose And Throat
Date Published: 01/27/2015

Notes: All devices

78 - - - -- Gastroenterological & Urological
Date Published: 01/27/2015

Notes: All devices

79 - - - -- General & Plastic Surgery
Date Published: 01/27/2015

Notes: All devices

80 - - - -- General Hospital/Personal Use
Date Published: 01/27/2015

Notes: All devices

84 - - - -- Neurological
Date Published: 01/27/2015

Notes: All devices

85 - - - -- Obstetrical & Gynecological
Date Published: 01/27/2015

Notes: All devices

86 - - - -- Ophthalmic
Date Published: 01/27/2015

Notes: All devices

87 - - - -- Orthopedic
Date Published: 01/27/2015

Notes: All devices

89 - - - -- Physical Medicine
Date Published: 01/27/2015

Notes: All devices

90 - - - -- Radiological
Date Published: 01/27/2015

Notes: All devices


KOREA (THE REPUBLIC OF)


Con Tech Korea Co. Ltd.
Date Published : 06/16/2014
Chunnan Techno College,Post Bi-A203 , Wolchul, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 06/16/2014

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 06/16/2014

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 06/16/2014

Desc: Contact Lenses

Contech Korea
Date Published : 06/16/2014
970-14 Wolchul-Dong , Gwangju, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 06/16/2014

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 06/16/2014

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 06/16/2014

Desc: Contact Lenses

Korea Pharma Co., Ltd.
Date Published : 03/29/2013
F8, Baeklim B/D , 823-33 Yoksam-Dong , Kangnam-Gu, Seoul, KOREA (THE REPUBLIC OF)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/29/2013

Notes: All Drugs

56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/29/2013

Notes: Antibiotics

60 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

61 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

62 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

63 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

64 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

65 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

66 - - - -- Human and Animal Drugs
Date Published: 03/29/2013

Notes: All Drugs

Polytouch Co Ltd
Date Published : 11/20/2014
108-1 Hyeopseok-Ri Namcheon-Myeon , Gyeongsan-si, KOREA (THE REPUBLIC OF)
73 - - - -- Anesthesiology
Date Published: 11/20/2014

74 - - - -- Cardiovascular
Date Published: 11/20/2014

76 - - - -- Dental
Date Published: 11/20/2014

77 - - - -- Ear,Nose And Throat
Date Published: 11/20/2014

78 - - - -- Gastroenterological & Urological
Date Published: 11/20/2014

79 - - - -- General & Plastic Surgery
Date Published: 11/20/2014

80 - - - -- General Hospital/Personal Use
Date Published: 11/20/2014

84 - - - -- Neurological
Date Published: 11/20/2014

85 - - - -- Obstetrical & Gynecological
Date Published: 11/20/2014

86 - - - -- Ophthalmic
Date Published: 11/20/2014

87 - - - -- Orthopedic
Date Published: 11/20/2014

89 - - - -- Physical Medicine
Date Published: 11/20/2014

90 - - - -- Radiological
Date Published: 11/20/2014


NETHERLANDS


Vision Direct Bv
Date Published : 08/27/2014
Distelweg 80 G 1031 , Amsterdam, NETHERLANDS
73 - - - -- Anesthesiology
Date Published: 08/27/2014

Notes: All Devices

74 - - - -- Cardiovascular
Date Published: 08/27/2014

Notes: All Devices

76 - - - -- Dental
Date Published: 08/27/2014

Notes: All Devices

77 - - - -- Ear,Nose And Throat
Date Published: 08/27/2014

Notes: All Devices

78 - - - -- Gastroenterological & Urological
Date Published: 08/27/2014

Notes: All Devices

79 - - - -- General & Plastic Surgery
Date Published: 08/27/2014

Notes: All Devices

80 - - - -- General Hospital/Personal Use
Date Published: 08/27/2014

Notes: All Devices

84 - - - -- Neurological
Date Published: 08/27/2014

Notes: All Devices

85 - - - -- Obstetrical & Gynecological
Date Published: 08/27/2014

Notes: All Devices

86 - - - -- Ophthalmic
Date Published: 08/27/2014

Notes: All Devices

87 - - - -- Orthopedic
Date Published: 08/27/2014

Notes: All Devices

89 - - - -- Physical Medicine
Date Published: 08/27/2014

Notes: All Devices

90 - - - -- Radiological
Date Published: 08/27/2014

Notes: All Devices


POLAND


BIOTECH SOLUTIONS KAMIL PALMOWSKI
Date Published : 02/05/2021
Ul. Karola Chodkiewicza 13a , Gdansk, Pomorskie POLAND
53 - - - -- Cosmetics
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

65 - - - -- Human and Animal Drugs
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

74 - - - -- Cardiovascular
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

79 - - - -- General & Plastic Surgery
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

87 - - - -- Orthopedic
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

BIOTECH SOLUTIONS KAMIL PALMOWSKI
Date Published : 02/05/2021
Ul. Swietojanska 44/36 , Gdynia, Pomorskie POLAND
53 - - - -- Cosmetics
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

65 - - - -- Human and Animal Drugs
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

74 - - - -- Cardiovascular
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

79 - - - -- General & Plastic Surgery
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

87 - - - -- Orthopedic
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

BIOTECH SOLUTIONS KAMIL PALMOWSKI
Date Published : 02/05/2021
Ul. Swietojanska 43/18 , Gdynia, Pomorskie POLAND
53 - - - -- Cosmetics
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

65 - - - -- Human and Animal Drugs
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

74 - - - -- Cardiovascular
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

79 - - - -- General & Plastic Surgery
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                

87 - - - -- Orthopedic
Date Published: 02/05/2021

Desc: Juvederm Ultra 2 (Cosmetics Containing Hyaluronic Acid)
Notes:                                                                                                                                                                                


TAIWAN


Morris Engineering Works Ltd.
Date Published : 09/16/2014
Kuan Tien Ind. District , No. 43 Kung Yeh Road , Tainan City, TAIWAN
73 - - - -- Anesthesiology
Date Published: 09/16/2014

74 - - - -- Cardiovascular
Date Published: 09/16/2014

76 - - - -- Dental
Date Published: 09/16/2014

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2014

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2014

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2014

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2014

84 - - - -- Neurological
Date Published: 09/16/2014

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2014

86 - - - -- Ophthalmic
Date Published: 09/16/2014

87 - - - -- Orthopedic
Date Published: 09/16/2014

89 - - - -- Physical Medicine
Date Published: 09/16/2014

90 - - - -- Radiological
Date Published: 09/16/2014


UNITED KINGDOM


Getlenses
Date Published : 08/27/2014
4 Opus Ave , York, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 08/27/2014

Notes: All devices

74 - - - -- Cardiovascular
Date Published: 08/27/2014

Notes: All devices

76 - - - -- Dental
Date Published: 08/27/2014

Notes: All devices

77 - - - -- Ear,Nose And Throat
Date Published: 08/27/2014

Notes: All devices

78 - - - -- Gastroenterological & Urological
Date Published: 08/27/2014

Notes: All devices

79 - - - -- General & Plastic Surgery
Date Published: 08/27/2014

Notes: All devices

80 - - - -- General Hospital/Personal Use
Date Published: 08/27/2014

Notes: All devices

84 - - - -- Neurological
Date Published: 08/27/2014

Notes: All devices

85 - - - -- Obstetrical & Gynecological
Date Published: 08/27/2014

Notes: All devices

86 - - - -- Ophthalmic
Date Published: 08/27/2014

Notes: All devices

87 - - - -- Orthopedic
Date Published: 08/27/2014

Notes: All devices

89 - - - -- Physical Medicine
Date Published: 08/27/2014

Notes: All devices

90 - - - -- Radiological
Date Published: 08/27/2014

Notes: All devices

Go Pro Now
Date Published : 11/20/2014
12 Manor Way , Bagshot, Surrey UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 11/20/2014

74 - - - -- Cardiovascular
Date Published: 11/20/2014

76 - - - -- Dental
Date Published: 11/20/2014

77 - - - -- Ear,Nose And Throat
Date Published: 11/20/2014

78 - - - -- Gastroenterological & Urological
Date Published: 11/20/2014

79 - - - -- General & Plastic Surgery
Date Published: 11/20/2014

80 - - - -- General Hospital/Personal Use
Date Published: 11/20/2014

84 - - - -- Neurological
Date Published: 11/20/2014

85 - - - -- Obstetrical & Gynecological
Date Published: 11/20/2014

86 - - - -- Ophthalmic
Date Published: 11/20/2014

87 - - - -- Orthopedic
Date Published: 11/20/2014

89 - - - -- Physical Medicine
Date Published: 11/20/2014

90 - - - -- Radiological
Date Published: 11/20/2014

Sclera Contact Lenses
Date Published : 10/31/2014
56 Games Road The Gatewaycockfosters , Cockfosterscockfosters, UNITED KINGDOM
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/31/2014

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/31/2014

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/31/2014

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/31/2014

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/31/2014

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/31/2014

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/31/2014

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/31/2014

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/31/2014

Desc: Contact Lenses

Vision Direct
Date Published : 08/27/2014
4 Opus Avenue Novus Business Park , Nether Poppleton, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 08/27/2014

Notes: All devices

74 - - - -- Cardiovascular
Date Published: 08/27/2014

Notes: All devices

76 - - - -- Dental
Date Published: 08/27/2014

Notes: All devices

77 - - - -- Ear,Nose And Throat
Date Published: 08/27/2014

Notes: All devices

78 - - - -- Gastroenterological & Urological
Date Published: 08/27/2014

Notes: All devices

79 - - - -- General & Plastic Surgery
Date Published: 08/27/2014

Notes: All devices

80 - - - -- General Hospital/Personal Use
Date Published: 08/27/2014

Notes: All devices

84 - - - -- Neurological
Date Published: 08/27/2014

Notes: All devices

85 - - - -- Obstetrical & Gynecological
Date Published: 08/27/2014

Notes: All devices

86 - - - -- Ophthalmic
Date Published: 08/27/2014

Notes: All devices

87 - - - -- Orthopedic
Date Published: 08/27/2014

Notes: All devices

89 - - - -- Physical Medicine
Date Published: 08/27/2014

Notes: All devices

90 - - - -- Radiological
Date Published: 08/27/2014

Notes: All devices


UNITED STATES


Block Scientific
Date Published : 06/06/2018
22 Sawgrass Dr , Bellport, NY 11713-1571 UNITED STATES
75 - - - -- Chemistry
Date Published: 06/06/2018

Notes: In vitro diagnostic products

81 - - - -- Hematology
Date Published: 06/06/2018

Notes: In vitro diagnostic products

82 - - - -- Immunology
Date Published: 06/06/2018

Notes: In vitro diagnostic products

83 - - - -- Microbiology
Date Published: 06/06/2018

Notes: In vitro diagnostic products

88 - - - -- Pathology
Date Published: 06/06/2018

Notes: In vitro diagnostic products

91 - - - -- Toxicology
Date Published: 06/06/2018

Notes: In vitro diagnostic products

92 - - - -- Molecular Genetics
Date Published: 06/06/2018

Notes: In vitro diagnostic products

Tua Usa Llc
Date Published : 01/27/2015
4560 Beltline Rd /# 400 , Addison, TX 75001 UNITED STATES
73 - - - -- Anesthesiology
Date Published: 01/27/2015

Notes: All devices

74 - - - -- Cardiovascular
Date Published: 01/27/2015

Notes: All devices

76 - - - -- Dental
Date Published: 01/27/2015

Notes: All devices

77 - - - -- Ear,Nose And Throat
Date Published: 01/27/2015

Notes: All devices

78 - - - -- Gastroenterological & Urological
Date Published: 01/27/2015

Notes: All devices

79 - - - -- General & Plastic Surgery
Date Published: 01/27/2015

Notes: All devices

80 - - - -- General Hospital/Personal Use
Date Published: 01/27/2015

Notes: All devices

84 - - - -- Neurological
Date Published: 01/27/2015

Notes: All devices

85 - - - -- Obstetrical & Gynecological
Date Published: 01/27/2015

Notes: All devices

86 - - - -- Ophthalmic
Date Published: 01/27/2015

Notes: All devices

87 - - - -- Orthopedic
Date Published: 01/27/2015

Notes: All devices

89 - - - -- Physical Medicine
Date Published: 01/27/2015

Notes: All devices

90 - - - -- Radiological
Date Published: 01/27/2015

Notes: All devices