Import Alert 95-05
(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 # 95-05
Published Date: 02/26/2024
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Electronic Products that Fail to Comply with Performance Standards or to Have Required Certification"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 12/29/2022 updates the guidance section including the agency contacts, and charge section. Changes to the import alert are bracketed by asterisks (***).
Reason for Alert:
The firms listed on the Red List for this alert, have been found to have one or more of the following objectionable conditions:
1) are subject to a CDRH Quality Control and Testing Program disapproval in accordance with section 534(h) of the FD&C Act, or;
2) do not appear to comply with the applicable performance standards prescribed pursuant to section 534 of the FD&C Act, or;
3) do not have the certification required by section 534(h) of the FD&C Act and as specified in 21 CFR 1010.2.
These conditions may include products without a permanently affixed label or tag, products for which evidence of a valid test and quality control program is lacking, or products for which the certification label is invalid because reports are deficient, and the firm has failed to provide requested information as required in 537(b).
Reason for Alert:
The firms listed on the Red List for this alert, have been found to have one or more of the following objectionable conditions:
1) are subject to a CDRH Quality Control and Testing Program disapproval in accordance with section 534(h) of the FD&C Act, or;
2) do not appear to comply with the applicable performance standards prescribed pursuant to section 534 of the FD&C Act, or;
3) do not have the certification required by section 534(h) of the FD&C Act and as specified in 21 CFR 1010.2.
These conditions may include products without a permanently affixed label or tag, products for which evidence of a valid test and quality control program is lacking, or products for which the certification label is invalid because reports are deficient, and the firm has failed to provide requested information as required in 537(b).
Guidance:
***Divisions may detain without physical examination (DWPE) shipments of specified electronic products from the firms identified on the Red List of this alert, which:***
1. Are subject to a CDRH Quality Control and Testing Program disapproval in accordance with section 534(h) of the FD&C Act; which pertains to the "NO TAG" violation charge, or;
2. Do not appear to comply, or have been determined to not comply, with the applicable performance standards prescribed pursuant to section 534 of the FD&C Act and as specified in 21 CFR Part 1010, 21 CFR 1040.10, and 1040.11, as applicable; which pertains to the "NON STD" violation charge, or;
3. Do not have the certification required under sections 534(h) and as specified in 21 CFR 1010.2.; which pertain to the "NO TAG" violation charge.
When Divisions encounter noncompliant submissions of electronic product(s) to which is not affixed a certification in the form of a label or tag in conformity with section 534(h) [NOT CERTIFIED, Section 536(a)] then the "NO TAG" charge code should be utilized.
When Divisions encounter noncompliant submissions of electronic product(s) offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA [NON STANDARD, Section 536(a)] then the "NON STD" charge code should be utilized.
In the event a Division encounters noncompliant submissions of electronic product(s) due to issues such as program disapproval, no certification label, or an invalid certification due to poor product reports which are also accompanied by observed failures to comply with the performance standard with the product at the port of entry then the Division should utilize both the "NO TAG" and "NON STD" charge code.
***A recommendation for addition to detention without physical examination, including analytical worksheets (if the product was analyzed), labeling, package inserts, user manuals, photographic evidence, website information, entry documents, etc., should be forwarded to the Division of Import Operations (DIO). DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH/OHT8: Office of Radiological Health/Electronic Products team.***
Released of Article Subject to Detention Without Physical Examination Under this Import Alert:
The owner, consignee, importer, and/or another responsible party to the shipment, may secure release of an individual shipment subject to DWPE, by submitting a written application (Form FDA 766) to FDA requesting authorization to bring an electronic product that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning)or providing requested information. Divisions will refer such applications related to this alert to ***CDRH/OHT8: Office of Radiological Health/Electronic Products Team.***
Removal from Detention without Physical Examination ***(REMOVE FROM RED LIST):***
To remove a firm's product from the Red List, information should be provided to the agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act).
Requests for removal should include the following information:
1. A complete product report that complies with 21 CFR 1002.7 and 1002.10, whether by submitting a new product report or by supplementing a prior product report with additional information that resolves FDA-identified deficiencies.
2. Evidence that the manufacturer's quality control and testing program is in compliance with the Electronic Product Radiation Control provisions of the FD&C Act (see Chapter V, Subchapter C of the FD&C Act) and 21 CFR 1010.2 and their laser products comply with the Federal Performance Standard for Laser Products (e.g., 21 CFR 1040.10 and 21 CFR 1040.11).
3. In addition, under 21 CFR 1002.10(k), the importer must provide other information CDRH may reasonably require to determine whether the importer is in compliance with the Electronic Product Radiation Control provisions and applicable standards.
***If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:***
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
***Questions or issues of policy, sample collection recommendations, or any other additional questions, should be addressed to CDRH/OHT8: Office of Radiological Health at RadHealth@fda.hhs.gov.
***
1. Are subject to a CDRH Quality Control and Testing Program disapproval in accordance with section 534(h) of the FD&C Act; which pertains to the "NO TAG" violation charge, or;
2. Do not appear to comply, or have been determined to not comply, with the applicable performance standards prescribed pursuant to section 534 of the FD&C Act and as specified in 21 CFR Part 1010, 21 CFR 1040.10, and 1040.11, as applicable; which pertains to the "NON STD" violation charge, or;
3. Do not have the certification required under sections 534(h) and as specified in 21 CFR 1010.2.; which pertain to the "NO TAG" violation charge.
When Divisions encounter noncompliant submissions of electronic product(s) to which is not affixed a certification in the form of a label or tag in conformity with section 534(h) [NOT CERTIFIED, Section 536(a)] then the "NO TAG" charge code should be utilized.
When Divisions encounter noncompliant submissions of electronic product(s) offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA [NON STANDARD, Section 536(a)] then the "NON STD" charge code should be utilized.
In the event a Division encounters noncompliant submissions of electronic product(s) due to issues such as program disapproval, no certification label, or an invalid certification due to poor product reports which are also accompanied by observed failures to comply with the performance standard with the product at the port of entry then the Division should utilize both the "NO TAG" and "NON STD" charge code.
***A recommendation for addition to detention without physical examination, including analytical worksheets (if the product was analyzed), labeling, package inserts, user manuals, photographic evidence, website information, entry documents, etc., should be forwarded to the Division of Import Operations (DIO). DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH/OHT8: Office of Radiological Health/Electronic Products team.***
Released of Article Subject to Detention Without Physical Examination Under this Import Alert:
The owner, consignee, importer, and/or another responsible party to the shipment, may secure release of an individual shipment subject to DWPE, by submitting a written application (Form FDA 766) to FDA requesting authorization to bring an electronic product that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning)or providing requested information. Divisions will refer such applications related to this alert to ***CDRH/OHT8: Office of Radiological Health/Electronic Products Team.***
Removal from Detention without Physical Examination ***(REMOVE FROM RED LIST):***
To remove a firm's product from the Red List, information should be provided to the agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act).
Requests for removal should include the following information:
1. A complete product report that complies with 21 CFR 1002.7 and 1002.10, whether by submitting a new product report or by supplementing a prior product report with additional information that resolves FDA-identified deficiencies.
2. Evidence that the manufacturer's quality control and testing program is in compliance with the Electronic Product Radiation Control provisions of the FD&C Act (see Chapter V, Subchapter C of the FD&C Act) and 21 CFR 1010.2 and their laser products comply with the Federal Performance Standard for Laser Products (e.g., 21 CFR 1040.10 and 21 CFR 1040.11).
3. In addition, under 21 CFR 1002.10(k), the importer must provide other information CDRH may reasonably require to determine whether the importer is in compliance with the Electronic Product Radiation Control provisions and applicable standards.
***If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:***
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
***Questions or issues of policy, sample collection recommendations, or any other additional questions, should be addressed to CDRH/OHT8: Office of Radiological Health at RadHealth@fda.hhs.gov.
***
Product Description:
Electronic products subject to the Federal Food, Drug, and Cosmetic Act that fail to comply with applicable performance standards.
Charge:
***For electronic products that appears to fail to comply with applicable performance standards:
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA. [NON STANDARD, Section 536(a)]
OASIS CHARGE CODE: NON STD
and/or
For electronic products that lack certification was not based upon a test or testing program meeting the requirements of section 534(h):
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h). [NOT CERTIFIED, Section 536(a)]
OASIS CHARGE CODE: NO TAG ***
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA. [NON STANDARD, Section 536(a)]
OASIS CHARGE CODE: NON STD
and/or
For electronic products that lack certification was not based upon a test or testing program meeting the requirements of section 534(h):
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h). [NOT CERTIFIED, Section 536(a)]
OASIS CHARGE CODE: NO TAG ***
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
BIG DIPPER LASER SCIENCE AND TEC
Date Published : 02/20/2024
Industrial , No.95-1 Langbei; Area, Tongde Communit
, Shenzhen,
CHINA
95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 02/20/2024
Desc: Laser Light Show Projector
Notes: NON STD; NO TAG
95 R - - DZ Low-Power Laser Light Show Projector, Display Products
Date Published: 02/20/2024
Desc: Laser Light Show Projector
Notes: NON STD; NO TAG
95 R - - EA High-Power Laser Light Show Projector (Output>5mW)
Date Published: 02/20/2024
Desc: Laser Light Show Projector
Notes: NON STD; NO TAG
95 R - - EB High-Power Laser Light Show, Display Products
Date Published: 02/20/2024
Desc: Laser Light Show Projector
Notes: NON STD; NO TAG
95 R - - EC Laser Video Projector, Display Products
Date Published: 02/20/2024
Desc: Laser Light Show Projector
Notes: NON STD; NO TAG
95 R - - IG Laser Illuminated Projector
Date Published: 02/20/2024
Desc: Laser Light Show Projector
Notes: NON STD; NO TAG
95 R - - IN Laser Illuminated Lighting Instrument
Date Published: 02/20/2024
Desc: Laser Light Show Projector
Notes: NON STD; NO TAG
Beijing Cosmelights Technology Co Ltd
Date Published : 12/10/2014
Room 2705 1 Xinghualu
, Beijingshi,
Beijingshi CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 12/10/2014
Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser)
Notes: class 2
79 O - - HT Light based over-the-counter hair removal
Date Published: 12/10/2014
Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser)
Notes: class 2
79 O - - NE Powered light based non-laser surgical instrument
Date Published: 12/10/2014
Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser)
Notes: class 2
Beijing Laserworld Int'l Import & Export, Co., Ltd
Date Published : 10/04/2012
Beiwu Village , Shunyi District
, Beijing,
Beijing CHINA
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 10/04/2012
Desc: Laser Engravers & Cutters (YH-GXXXX series)
95 R - - HK Laser marker or engraver
Date Published: 10/04/2012
Desc: Laser Engravers & Cutters (YH-GXXXX series)
Beijing Shizhengfang Science and Technology Dev. Co., LTD.
Date Published : 02/14/2013
Three Gorges Merchant Bldg Room 311 , No. 11 Jiuxian Bridge Road Jia
, Beijing,
Chaoyang District CHINA
90 I - - YL Collimator, Dermatological, Therapeutic X-Ray
Date Published: 02/14/2013
Desc: F7 C02 Fractional Laser
95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 02/14/2013
Desc: F7 C02 Fractional Laser
95 R - - HL Laser therapy product
Date Published: 02/14/2013
Desc: F7 C02 Fractional Laser
CHANGSHU WOJUN MACHINERY EQUIPME
Date Published : 12/27/2021
Fuya Road Bldg 18 , 7 Bi
, Changshu,
CHINA
95 R - - HK Laser marker or engraver
Date Published: 12/27/2021
Desc: Laser Engraver Model -3040T/2.5W
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 12/27/2021
Desc: Laser Engraver Model 3040T/5.5W
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 12/27/2021
Desc: Laser Engraver Model 3040T/7W
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 12/27/2021
Desc: Laser Engraver Model 3040T/0.5W
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 12/27/2021
Desc: Laser Engraver Model YZDKJ15W
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 12/27/2021
Desc: Laser Engraver Model 3040T/15W
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 12/27/2021
Desc: Laser Engraver Model DKJ2418
Notes: NON STD
E3 LASER SHENZHEN BEC LASER TECHCO LTD
Date Published : 07/19/2021
4th F Building 4 Yijiang Industrial Park Huaming Rddalang St
, Guangdong,
CHINA
95 R - - HK Laser marker or engraver
Date Published: 07/19/2021
Desc: Laser Marking Machine
Notes: NON STD, NO TAG
Goldensign International Technology Co.Ltd
Date Published : 09/25/2019
Room 2212-2216 Floor 22ND , NO. 58 Jinxinlu; Pudongxin
, Shanghai,
Shanghai CHINA
95 R - - HK Laser marker or engraver
Date Published: 09/25/2019
Desc: LASER MARKING MACHINE
Notes: NON STD & NO TAG
Guangzhou Han Ma Automation Control Equipment Co. Ltd.
Date Published : 08/20/2020
No. 6 Huashan Rd , Panyu District
, Guangzhou,
Guangdong CHINA
95 R - - -- Portion of device code
Date Published: 08/20/2020
Desc: Laser product
Notes: NON STD
Guangzhou Yue Xiu Enterprises Holdings Corp
Date Published : 09/16/2009
11/F Guangzhou International Trade Bldg.
, Guangzhou Dadao Zhong,Guangzhou, China,
CHINA
96 R - - CR Microwave Oven, Consumer (Food Prep)
Date Published: 12/28/2022
Notes: 11/26/2001
HK SISHUN TRADE CO., LTD
Date Published : 09/11/2020
No.3 Fuya Road, Dongzhang Town
, Jiangsu,
CHINA
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 09/11/2020
Desc: Laser Marking Machine
Notes: NON STD; NO TAG
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 09/11/2020
Desc: Glass Laser Tube
Notes: NON STD; NO TAG
95 R - - -- Portion of device code
Date Published: 09/11/2020
Desc: Laser product
Notes: NON STD; NO TAG
JINAN SENFENG TECHNOLOGY CO. LTD
Date Published : 02/26/2024
Yaoqoamg Street Office , No. 6333 North Lingangroad
, Jinan,
CHINA
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 02/26/2024
Desc: All laser Products
Notes: NON STD; NO TAG
95 R - - FF Laser Welder, Materials Processing Laser Products
Date Published: 02/26/2024
Desc: All laser Products
Notes: NON STD; NO TAG
95 R - - HK Laser marker or engraver
Date Published: 02/26/2024
Desc: All laser Products
Notes: NON STD; NO TAG
95 R - - IM Laser marker or engraver, tabletop, consumer
Date Published: 02/26/2024
Desc: All laser Products
Notes: NON STD; NO TAG
Jinan G Weike Science & Technology Co.,Ltd
Date Published : 04/20/2020
C-504 in Hi Tech Square Hig , Tech Zone
, Jinan,
CHINA
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 04/20/2020
Desc: LASER CUTTING MACHINE MODELS LC1325D and LF1325L
Notes: NON STD. NO TAG
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 04/20/2020
Desc: LASER CUTTING MACHINE MODEL LG900N
Notes: NON STD.
95 R - - HK Laser marker or engraver
Date Published: 04/20/2020
Desc: LASER FIBER MARKING MACHINE MODEL LF50
Notes: NON STD. NO TAG
95 R - - -- Portion of device code
Date Published: 11/03/2021
Desc: All Laser Products
Notes: NON STD
Jinan Morn Technology
Date Published : 03/30/2021
Golden Times High 1587 , Chonghualu; Licheng
, Jinan,
Shandong CHINA
95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 03/30/2021
Desc: Laser Marking Machine (all models)
Notes: NON STD, NO TAG
95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 03/30/2021
Desc: Laser Engraving and Cutting Machine (all models)
Notes: NON STD, NO TAG
95 R - - EM Spectroscopy Instrument, Laser, Research Scientific, Laboratory Laser Products
Date Published: 03/30/2021
Desc: Laser Engraving and Cutting Machine (all models)
Notes: NON STD, NO TAG
95 R - - ER Alignment Laser Product, Surveying Leveling, Alignment Laser Products
Date Published: 03/30/2021
Desc: Laser Marking Machine (all models)
Notes: NON STD, NO TAG
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 03/30/2021
Desc: Laser Marking Machine (all models)
Notes: NON STD, NO TAG
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 03/30/2021
Desc: Laser Engraving and Cutting Machine (all models)
Notes: NON STD, NO TAG
95 R - - HK Laser marker or engraver
Date Published: 03/30/2021
Desc: Laser Engraving and Cutting Machine (all models)
Notes: NON STD, NO TAG
95 R - - HK Laser marker or engraver
Date Published: 03/30/2021
Desc: Laser Marking Machine (all models)
Notes: NON STD, NO TAG
95 R - - IM Laser marker or engraver, tabletop, consumer
Date Published: 03/30/2021
Desc: Laser Marking Machine (all models)
Notes: NON STD, NO TAG
Jinan Robotec Machinery Co LTD
Date Published : 07/01/2019
1 1224 Bldg 1 No 88 Wes
, Shandong,
CHINA
95 R - - HK Laser marker or engraver
Date Published: 07/01/2019
Desc: Laser Engraving Machine
Notes: NON STANDARD; NOT CERTIFIED
Jinan Senfeng Laser Technology Co. Ltd.
Date Published : 02/26/2024
F4-6-601, Innovation Workshop Park , No. 2016 Feiyue Avenue, High-tech Zone
, Jinan,
Shandong CHINA
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 02/26/2024
Desc: All laser Products
Notes: NON STD; NO TAG
95 R - - FF Laser Welder, Materials Processing Laser Products
Date Published: 02/26/2024
Desc: All laser Products
Notes: NON STD; NO TAG
95 R - - HK Laser marker or engraver
Date Published: 02/26/2024
Desc: All laser Products
Notes: NON STD; NO TAG
95 R - - IM Laser marker or engraver, tabletop, consumer
Date Published: 02/26/2024
Desc: All laser Products
Notes: NON STD; NO TAG
Lanxi Yibu Lighting Co.,LTD
Date Published : 10/25/2012
No. 9 Sanziqiao Road , Economic Development Zone
, Lanxi,
Zhejiang CHINA
95 R - - DX Mercury Vapor Lamp
Date Published: 10/25/2012
Desc: Mercury Vapor Lamp
Liaocheng Ray Fine Technology Co.
Date Published : 11/04/2019
Dongchang East Rd
, Liaocheng,
Shandong CHINA
95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 11/04/2019
Desc: Laser Marking Machine
Notes: NON STD & NO TAG
95 R - - EU Laser Aiming Product, Visible, Surveying, Leveling, Alignment Laser Products
Date Published: 11/04/2019
Desc: Laser Marking Machine
Notes: NON STD & NO TAG
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 11/04/2019
Desc: Laser Marking Machine
Notes: NON STD & NO TAG
95 R - - FI Print Industry Plate Maker, Material Processing Laser Products
Date Published: 11/04/2019
Desc: Laser Marking Machine
Notes: NON STD & NO TAG
95 R - - HH LED, General Purpose Illumination, General Optical Products, Non-Medical
Date Published: 11/04/2019
Desc: Laser Marking Machine
Notes: NON STD & NO TAG
95 R - - HK Laser marker or engraver
Date Published: 11/04/2019
Desc: Laser Marking Machine
Notes: NON STD & NO TAG
ONETECH MEDICAL EQUIPMENT CO LIM
Date Published : 07/31/2017
19 YINGBIN
, Guangzhou,
Guangdong CHINA
90 E - - HD Unit, X-Ray, Extraoral With Timer
Date Published: 11/08/2018
Desc: Dental X Ray Machine
Notes: Class II
90 M - - UH System, X-Ray, Extraoral Source, Digital
Date Published: 07/31/2017
Desc: Dental X Ray Machine
Notes: Class II
SHANGHAI SISHUN MACHINERY CO., LIMITED
Date Published : 09/11/2020
3131 Jinshajiang Road J , NO. 3131 JINSHAJIANG ROAD, JIADING DISTRICT
, Shanghai,
CHINA
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 09/11/2020
Desc: Glass Laser Tube
Notes: NO STD; NO TAG
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 09/11/2020
Desc: Laser Marking Machine
Notes: NO STD; NO TAG
95 R - - -- Portion of device code
Date Published: 09/11/2020
Desc: Laser product
Notes: NO STD; NO TAG
SHANGHAI XINDUN TRADE CO LTD
Date Published : 03/24/2021
Rm 1, Bldg 2, 3131 Jins
, Shanghai,
CHINA
95 R - - HK Laser marker or engraver
Date Published: 03/24/2021
Desc: Laser Engraver Model DKJ3018
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 03/24/2021
Desc: Laser Engraver Model DKJ2418
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 03/24/2021
Desc: Laser Engraver Model DKJ4050
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 03/24/2021
Desc: Laser Engraver Model DKJ2419
Notes: NON STD
95 R - - HK Laser marker or engraver
Date Published: 03/24/2021
Desc: Laser Engraver Model DKJ1610
Notes: NON STD
SHENZHEN BEC LASER TECH CO., LTD
Date Published : 02/03/2021
Bld 4 4th Flr , Longhua Dist
, Shenzhen,
Guangdong CHINA
95 R - - HK Laser marker or engraver
Date Published: 02/03/2021
Desc: Laser Welding Machine
Notes: NON STD, NO TAG
SHENZHEN HINGIN TECH CO.,LTD.
Date Published : 11/03/2023
Building A1 B9-B11 Floor 2 , B9-B11,FLOOR 2, BUILDING A1, RED BOX CREATIVE PARK
, Shenzhen,
Guangdong CHINA
95 R - - -- Portion of device code
Date Published: 11/03/2023
Desc: Laser product
Notes: NON STD; DWPE date 8/24/2020
SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD
Date Published : 11/12/2019
Building No F 51 , 5 Qiongyulu; Nanshan
, Shenzhen,
Guangdong CHINA
95 R - - HL Laser therapy product
Date Published: 11/12/2019
Desc: Cold Laser System for Veterinary
Notes: NON STD & NO TAG
SHENZHEN TRONXY TECHNOLOGY CO.,LTD
Date Published : 08/13/2021
No.23 Baoya Road , Danzhutou Community,Longgang District
, Shenzhen,
Guangdong CHINA
95 R - - HK Laser marker or engraver
Date Published: 08/13/2021
Desc: Laser Engraver Module
Notes: NON STD; NO TAG
TCL Holdings Co., Ltd.
Date Published : 09/16/2009
No. 6 Eling South Road
, Huizhou,
Guangdong CHINA
94 R - - AZ Television Receiver, Medical Imaging, Color
Date Published: 12/28/2022
Desc: TV Receivers/Computer
Notes: 6/1/2001
94 R - - BA Television Receiver, Medical Imaging Monochrome
Date Published: 12/28/2022
Desc: TV Receivers/Computer
Notes: 6/1/2001
94 R - - BB Television Receiver, General Purpose, Color
Date Published: 12/28/2022
Desc: TV Receivers/Computer
Notes: 6/1/2001
94 R - - BC Television Receiver, General Purpose, Monochrome
Date Published: 12/28/2022
Desc: TV Receivers/Computer
Notes: 6/1/2001
Wuhan Huahai Century Laser Co. Ltd.
Date Published : 10/03/2019
FUHUSHAN INDUSTRY PARK. NO 87, ZHUODAOQUAN ROAD , HONGSHAN DISTRICT
, Wuhan,
Hubei CHINA
95 R - - HK Laser marker or engraver
Date Published: 10/03/2019
Desc: FIBER LASER MARKING MACHINE
Notes: NON STD & NO TAG
Zhongshan Baitian Photoelectric Technology Co. Ltd. (dba Magnum Lighting Technology Co. Ltd.)
Date Published : 06/28/2019
Bldg. 9 West Floor 2 Floor 2 , Qifang Ind. Zone
, Zhongshan,
CHINA
95 R - - DZ Low-Power Laser Light Show Projector, Display Products
Date Published: 06/28/2019
Desc: ML-1000 laser light show projector
Notes: NON STANDARD
95 R - - EA High-Power Laser Light Show Projector (Output>5mW)
Date Published: 06/28/2019
Desc: ML-1000 laser light show projector
Notes: NON STANDARD
95 R - - EB High-Power Laser Light Show, Display Products
Date Published: 06/28/2019
Desc: ML-1000 laser light show projector
Notes: NON STANDARD
HONG KONG SAR
HK SISHUN TRADE CO LIMITED
Date Published : 09/11/2020
21f Centrak 88 Des Voex
, Central,
HONG KONG SAR
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 09/11/2020
Desc: Glass Laser Tube
Notes: NON STD; NO TAG
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 09/11/2020
Desc: Laser Marking Machine
Notes: NON STD; NO TAG
95 R - - -- Portion of device code
Date Published: 09/11/2020
Desc: Laser product
Notes: NON STD; NO TAG
ITALY
Biorem S.R.L.
Date Published : 09/16/2009
Via Francesco Angrisani 18A
, Agropoli,
Salerno ITALY
79 G - - EX Powered laser surgical instruments
Date Published: 09/16/2009
Notes: SkiMaster Micro-dermabrasion products 1/2/2002
79 G - - FD Dermatome
Date Published: 09/16/2009
Notes: SkiMaster Micro-dermabrasion products 1/2/2002
Formenti Seleco S.P.A.
Date Published : 09/16/2009
V. Dante Alighieri, 43
, Lissone,
MI ITALY
94 R - - AZ Television Receiver, Medical Imaging, Color
Date Published: 12/28/2022
Desc: Television Receivers/Computer Monitors
Notes: 4/17/2003
94 R - - BA Television Receiver, Medical Imaging Monochrome
Date Published: 12/28/2022
Desc: Television Receivers/Computer Monitors
Notes: 4/17/2003
94 R - - BB Television Receiver, General Purpose, Color
Date Published: 12/28/2022
Desc: Television Receivers/Computer Monitors
Notes: 4/17/2003
94 R - - BC Television Receiver, General Purpose, Monochrome
Date Published: 12/28/2022
Desc: Television Receivers/Computer Monitors
Notes: 4/17/2003