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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device media, reproductive
Regulation Description Reproductive media and supplements.
Product CodeMQL
Regulation Number 884.6180
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTSMEDIA DENMARK APS
  SUBSTANTIALLY EQUIVALENT 3
CASEBIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DONNEVIE MEDICAL TECHNOLOGY (SHANGHAI) CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
ECMPC, LLC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
GIMBO MEDICAL TECHNOLOGY SHENZHEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
HAMILTON THORNE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
KITAZATO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ORIGIO A/S, A COOPERSURGICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG WEGO RUISHENG MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
VITROLIFE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 2
VITROMED GMBH
  SUBSTANTIALLY EQUIVALENT 6
VITROMED LANGENFELD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HORIZON MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 2 2
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Sep-26-2024
2 CooperSurgical, Inc. II Feb-14-2024
3 CooperSurgical, Inc. II Apr-06-2023
4 CooperSurgical, Inc. II Jan-31-2023
5 CooperSurgical, Inc. II Jul-20-2022
6 CooperSurgical, Inc. II Oct-13-2020
7 Fujifilm Irvine Scientific, Inc. II Feb-06-2024
8 Fujifilm Irvine Scientific, Inc. II Apr-01-2023
9 Fujifilm Irvine Scientific, Inc. II Nov-17-2021
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