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KEYU Automatic Urine Analysis System
EUDAMEDClass IVD General (EU MDR)
Ref KU-3000
Identity
- Trade Name
- KEYU Automatic Urine Analysis System EUDAMED
- Device Name
- Automatic Urine Analysis System EUDAMED
- Model / Reference
- KU-3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361917 EUDAMED
- Basic UDI-DI
- B-06974735361917 EUDAMED
- EMDN Code
- W020101020103 AUTOMATED URINE ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
KEYU Automatic Urine Analysis System by Zhuhai Keyu Biological Engineering Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06974735361917 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 2e6736e8-3dd5-4183-9f97-cc8af22352dc 61 fields · synced Jun 18, 2026