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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device labware, assisted reproduction
Regulation Description Assisted reproduction labware.
Product CodeMQK
Regulation Number 884.6160
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
BONRAYBIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CYTOSWIM LTD
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
GIMBO MEDICAL TECHNOLOGY SHENZHEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU HEHONG BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HERTART APS
  SUBSTANTIALLY EQUIVALENT 1
IPREG INCORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MOTILITYCOUNT APS
  SUBSTANTIALLY EQUIVALENT 1
ORIGIO A/S
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE A/S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II May-17-2022
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