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KEYU Maintenance Solution
EUDAMEDClass A (EU MDR)
Ref KU-M03Ref KU-M02Ref KU-M01
Identity
- Trade Name
- KEYU Maintenance Solution EUDAMED
- Device Name
- Maintenance Solution EUDAMED
- Model / Reference
- KU-M03 EUDAMEDKU-M02 EUDAMEDKU-M01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360712 EUDAMED06974735360569 EUDAMED06974735360071 EUDAMED
- Basic UDI-DI
- 697473536KUC03PJ 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 Maintenance 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 | 697473536KUC03PJ | 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 (3)
- EUDAMED d96e4007-affc-4b4a-8a71-ac3d7f45e453 61 fields · synced Jul 15, 2026
- EUDAMED 702c7cf8-5809-4de8-ad26-653ec7310886 61 fields · synced May 18, 2026
- EUDAMED 1c0b9c4a-b709-440f-99e2-169dbb144fe3 61 fields · synced May 18, 2026