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Bioteque FS3000

by Bioteque Taiwan Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719894432106 UDI-DI Date2 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bioteque
Generic Name
Pelvic-organ-supporting pessary
Model / Reference
FS3000
Primary DI / UDI-DI
04719894432106
510(k) Number
FDA Product Code
HHW
GMDN Term
Pelvic-organ-supporting pessary
Device Class
Class II
Regulation Number
884.3575
GUDID distribution status
In Commercial Distribution

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Other devices from Bioteque Taiwan Ltd.

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Properties

  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No