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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device device, fertility diagnostic, contraceptive, software application
Definition Designed to monitor and provide fertility information to prevent pregnancy (contraception).
Product CodePYT
Regulation Number 884.5370
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOWINK GMBH
  SUBSTANTIALLY EQUIVALENT 1
NATURAL CYCLES NORDIC AB
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Abortion 1 1
Pregnancy 1 1

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