Identity
- Trade Name
- Bioteque Taiwan Ltd. FDA UDI
- Generic Name
- Pelvic-organ-supporting pessary FDA UDI
- Model / Reference
- OV6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719894431239 FDA UDI
- 510(k) Number
- K092981 FDA UDI
- FDA Product Code
- HHW FDA UDI
- GMDN Term
- Pelvic-organ-supporting pessary FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.3575 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Pelvic-organ-supporting pessary
Bioteque Taiwan Ltd.'s Pessary is a unique device designed to provide support for women's pelvic organs, helping to prevent prolapse and maintain optimal health. Our reusable pessary is made of soft materials, available in various shapes and sizes, and can be fitted individually to each woman's needs.
Similar devices
Also classified as Pelvic-organ-supporting pessary.
- MILEX — CooperSurgical, Inc. · Class II
- Milex — CooperSurgical, Inc. · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- MILEX — CooperSurgical, Inc. · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Milex — CooperSurgical, Inc. · Class II
Cleared under the same submission
K092981 also covers:
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioteque Taiwan Ltd.
Sources (1)
- FDA UDI c6b76319-e621-4e66-b363-2d7cba91b125 33 fields · synced Jul 16, 2026