Identity
- Trade Name
- Bioteque Taiwan Ltd. FDA UDI
- Generic Name
- Uterine sound, single-use FDA UDI
- Device Name
- Uterine Sound EUDAMED
- Model / Reference
- BA100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719894432847 EUDAMEDFDA UDI
- Basic UDI-DI
- 4719894430801AM EUDAMED
- FDA Product Code
- HHM FDA UDI
- EMDN Code
- U089003 HYSTEROMETERS, SINGLE-USE EUDAMED
- GMDN Term
- Uterine sound, 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Uterine sound, 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
European Union Unknown
MDR
United States Pending data
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 fd0c1b3c-5122-4527-be66-b7d9782d4e85 32 fields · synced Aug 1, 2026
- EUDAMED 01312250-225b-4bf7-a04e-592175fcc7d7 61 fields · synced Jul 28, 2026