Identity
- Trade Name
- KEYU Urine Chemistry QC EUDAMED
- Device Name
- Urine Chemistry QC EUDAMED
- Model / Reference
- C-UC-2 EUDAMEDC-UC-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361375 EUDAMED06974735361368 EUDAMED
- Basic UDI-DI
- B-06974735361375 EUDAMEDB-06974735361368 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
EUDAMEDEUDAMED
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 Chemistry QC by Zhuhai Keyu Biological Engineering 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-06974735361375 | 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 (3)
- EUDAMED 6ee55218-b540-4495-892a-0806efcdece8 61 fields · synced Jul 14, 2026
- EUDAMED b34f7cf4-83a9-4599-b2ac-2d3eeda167b5 61 fields · synced May 19, 2026
- EUDAMED a74eb561-ab63-4615-b792-8c7291f284d1 61 fields · synced Jul 13, 2026