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Urine Analyzer
EUDAMEDClass A (EU MDR)
Ref WHY120FAModel WHY120FA, WHY130FA, WHY140FA, WHY160FA, WHY170FA&WHY160FA, WHY170FA
Identity
- Trade Name
- Urine Analyzer EUDAMED
- Device Name
- Urine Analyzer EUDAMED
- Model / Reference
- WHY120FA, WHY130FA, WHY140FA, WHY160FA, WHY170FA&WHY160FA, WHY170FA EUDAMEDWHY120FA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226450350 EUDAMED
- Basic UDI-DI
- 697722645BTUA01QA EUDAMED
- EMDN Code
- W020101020101 URINE STRIP READERS 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
No
EUDAMED
Urine Analyzer by Nanjing Poweam Medical 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 | 697722645BTUA01QA | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Poweam Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000040207
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f89d7591-dbab-404d-9b7f-42d298ceca6e 61 fields · synced Jun 19, 2026