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KEYU Urine Sediment Analyzer Quality Control
EUDAMEDClass IVD General (EU MDR)
Ref KU-UQC-03Ref KU-UQC-02
Identity
- Trade Name
- KEYU Urine Sediment Analyzer Quality Control EUDAMED
- Device Name
- Urine Sediment Analyzer Quality Control EUDAMED
- Model / Reference
- KU-UQC-03 EUDAMEDKU-UQC-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360491 EUDAMED06974735360484 EUDAMED
- Basic UDI-DI
- B-06974735360491 EUDAMEDB-06974735360484 EUDAMED
- EMDN Code
- W0101050102 UNASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
KEYU Urine Sediment Analyzer Quality Control 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-06974735360491 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 9178f30f-042f-4871-95ad-2da0f2cca9c0 61 fields · synced Jul 30, 2026
- EUDAMED bd2633fd-469c-4e9c-bd31-453fb63263b2 61 fields · synced May 17, 2026