Identity
- Trade Name
- Bioteque Taiwan Ltd. FDA UDI
- Generic Name
- Pelvic-organ-supporting pessary FDA UDI
- Model / Reference
- CPs5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719894430706 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. by Bioteque Taiwan Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pelvic-organ-supporting pessary.
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- Milex — CooperSurgical, Inc. · Class II
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- 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 |
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Manufacturer
- Manufacturer
- Bioteque Taiwan Ltd.
Sources (1)
- FDA UDI 1d6c70e3-9ea3-4005-aa1b-ebb5f7da0b10 33 fields · synced Jun 6, 2026