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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, assisted reproduction
Regulation Description Assisted reproduction needles.
Product CodeMQE
Regulation Number 884.6100
Device Class 2


Premarket Reviews
ManufacturerDecision
GIMBO MEDICAL TECHNOLOGY SHENZHEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VITAVITRO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HORIZON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 2 2
2023 37 37
2024 20 20
2025 37 37
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 92 92
Dull, Blunt 10 10
Insufficient Device Problem Information 7 7
Manufacturing, Packaging or Shipping Problem 4 4
Material Disintegration 2 2
Scratched Material 2 2
Defective Component 1 1
Defective Device 1 1
Material Twisted/Bent 1 1
Optical Problem 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Blood Loss/Bleeding 86 86
No Clinical Signs, Symptoms or Conditions 16 16
Intra-Abdominal Hemorrhage 9 9
Perforation 4 4
Syncope/Fainting 1 1
Hematoma 1 1
Intermenstrual Bleeding 1 1
Insufficient Information 1 1

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