Identity
- Trade Name
- Urine Analyzer EUDAMED
- Device Name
- Urine analyzer EUDAMED
- Model / Reference
- UA-201 EUDAMEDUC-201-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975519630885 EUDAMED
- Basic UDI-DI
- B-06975519630885 EUDAMED
- EMDN Code
- W02010701 URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Urine Analyzer by Hangzhou Bosure Biotech 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-06975519630885 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bosure Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000003001
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED f9cb40c8-5a5a-45f5-b247-a49cc2c1b1de 61 fields · synced Jun 18, 2026