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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
Regulation Description Software application for contraception.
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
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2023 2 2

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

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