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KEYU Urine Analyzer Diluent Solution
EUDAMEDClass A (EU MDR)
Ref KU-D01Ref KU-D04Ref KU-D02Ref KU-D03
Identity
- Trade Name
- KEYU Urine Analyzer Diluent Solution EUDAMED
- Device Name
- Urine Analyzer Diluent Solution EUDAMED
- Model / Reference
- KU-D01 EUDAMEDKU-D04 EUDAMEDKU-D02 EUDAMEDKU-D03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360057 EUDAMED06974735360705 EUDAMED06974735360545 EUDAMED06974735360552 EUDAMED
- Basic UDI-DI
- 697473536KUC02PG 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 Diluent 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 | 697473536KUC02PG | 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 (4)
- EUDAMED 2758a9c7-07e5-410b-88cf-3715aae918ff 61 fields · synced Oct 6, 2026
- EUDAMED 5311cb31-6e4b-4091-861c-6444f336fc07 61 fields · synced May 18, 2026
- EUDAMED b4834f9a-d9fc-4b06-956f-195910cc4a66 61 fields · synced May 19, 2026
- EUDAMED 319ebabe-24c1-4203-8eee-3f84bd7c6797 61 fields · synced May 19, 2026