Skip to content

LTL Medical R3

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 Number04719894436265 UDI-DI Date24 Jul 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  • Withdrawn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
LTL Medical
Generic Name
Pelvic-organ-supporting pessary
Model / Reference
R3
Primary DI / UDI-DI
04719894436265
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

Related devices

Cleared under the same submission (K092981)

Show all (12)

Other devices from Bioteque Taiwan Ltd.

See all devices from Bioteque Taiwan Ltd. →

Properties

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

Other properties (10)

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