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Béa Fertility BTK-US-01

by Stepone Fertility Ltd United States GUDID

Product code HDR

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05065015660064 UDI-DIDate24 Jul 2025ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
Béa Fertility
Generic Name
Conceptive cervical cap, single-use
Model / Reference
BTK-US-01
Primary DI / UDI-DI
05065015660064
FDA Product Code
HDR, FMH, OBB
GMDN Term
Conceptive cervical cap, single-use
Device Class
Class II
Regulation Number
884.5250, 864.3250
Commercial Distribution
In Commercial Distribution

Related devices

Category: Conceptive cervical cap, single-use

Other devices from Stepone Fertility Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 1491dd5d-6013-4155-9aa7-ab466502c9a9 33 fields · synced 23 Oct 2026