Identity
- Trade Name
- KEYU Urine Sediment QC EUDAMED
- Device Name
- Urine Sediment QC EUDAMED
- Model / Reference
- C-US-2 EUDAMEDC-US-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361313 EUDAMED06974735361320 EUDAMED
- Basic UDI-DI
- B-06974735361313 EUDAMEDB-06974735361320 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 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-06974735361313 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 75832ccb-ba87-4bb8-8e2f-2ff2cf71fa62 61 fields · synced Jul 12, 2026
- EUDAMED 270ffaac-9b0a-4262-b61b-07962d020484 61 fields · synced May 18, 2026