Identity
- Trade Name
- KEYU Sample Collection Tube EUDAMED
- Device Name
- Sample Collection Tube EUDAMED
- Model / Reference
- C-U-12-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361450 EUDAMED
- Basic UDI-DI
- 697473536KUC20PJ EUDAMED
- EMDN Code
- W05010202 URINE COLLECTION, TUBES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
KEYU Sample Collection Tube by Zhuhai Keyu Biological Engineering 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 | 697473536KUC20PJ | Class A | 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 03fa20cc-9bcc-4cbe-bcf8-034873506ec1 61 fields · synced Jun 20, 2026