Identity
- Device Name
- Urine Analyzer EUDAMED
- Model / Reference
- BW-500MINI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974410140001 EUDAMED
- Basic UDI-DI
- 697441014UA000162 EUDAMED
- EMDN Code
- W02010701 URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
New Device
Yes
EUDAMED
Urine Analyzer by Bioway Biological Technology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697441014UA000162 | Class A | Active |
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Manufacturer
- Manufacturer
- Bioway Biological Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000026464
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 906b2f90-d713-407f-84b1-8d8fbaf1988d 61 fields · synced Jun 18, 2026