Identity
- Trade Name
- KEYU Urine Analyzer Cleaning Solution EUDAMED
- Device Name
- Urine Analyzer Cleaning Solution EUDAMED
- Model / Reference
- KU-C-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360040 EUDAMED
- Basic UDI-DI
- 697473536KUC01PE EUDAMED
- EMDN Code
- W02010785 URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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 Urine Analyzer Cleaning Solution 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 | 697473536KUC01PE | Class A | 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 (1)
- EUDAMED e0990f22-29c4-4177-b07b-a2e46810552b 61 fields · synced Jun 19, 2026