Bioteque Taiwan Ltd.
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Bioteque Taiwan Ltd. FDA UDI
- Generic Name
- Fixed-diameter cervical dilator, single-use FDA UDI
- Device Name
- Disposable Cervical Dilator EUDAMED
- Model / Reference
- OS265BA-2 EUDAMEDFDA UDIDisposable Cervical Dilator EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719894432441 EUDAMEDFDA UDI
- Basic UDI-DI
- 47198944304019Z EUDAMED
- FDA Product Code
- HDQ FDA UDI
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
- GMDN Term
- Fixed-diameter cervical dilator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Fixed-diameter cervical dilator, single-use
Bioteque Taiwan Ltd. by Bioteque Taiwan Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bioteque Taiwan Ltd.
Sources (2)
- FDA UDI 251146e8-ff0e-4d04-a2a7-d47aae03248f 32 fields · synced Jul 11, 2026
- EUDAMED 93f9158b-609e-40b5-bcb4-90e3ec5f3b07 61 fields · synced Jul 11, 2026