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Bioteque America, Inc. BA051F

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 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810142352437 UDI-DI Date2 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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 America, Inc.
Generic Name
Intrauterine imaging medium catheter
Model / Reference
BA051F
Primary DI / UDI-DI
00810142352437
510(k) Number
FDA Product Code
LKF
GMDN Term
Intrauterine imaging medium catheter
Device Class
Class II
Regulation Number
884.4530
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K092983)

Show all (12)

Other devices from Bioteque Taiwan Ltd.

See all devices from Bioteque Taiwan Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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