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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microscope and microscope accessories, reproduction, assisted
Regulation Description Assisted reproductive microscopes and microscope accessories.
Product CodeMTX
Regulation Number 884.6190
Device Class 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 2 2
Tear, Rip or Hole in Device Packaging 2 2
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Zeiss, Carl Inc III Jul-25-2022
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