Identity
- Model / Reference
- URS-12H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974410142053 EUDAMED
- Basic UDI-DI
- B-06974410142053 EUDAMED
- EMDN Code
- W01010901 URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Urs-12h by Bioway Biological Technology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974410142053 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioway Biological Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000026464
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b21f4a5d-e2bd-4f30-9694-27d6f6c48c10 61 fields · synced Jul 26, 2026