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KEYU Sample Diluent
EUDAMEDClass A (EU MDR)
Ref KU-R02-1Ref KU-R02-3Ref KU-R02-2Ref KU-R02-4
Identity
- Trade Name
- KEYU Sample Diluent EUDAMED
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- KU-R02-1 EUDAMEDKU-R02-3 EUDAMEDKU-R02-2 EUDAMEDKU-R02-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360088 EUDAMED06974735360583 EUDAMED06974735360576 EUDAMED06974735360590 EUDAMED
- Basic UDI-DI
- 697473536KUC05PN EUDAMED
- EMDN Code
- W0101070304 COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES) 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 Sample Diluent 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 | 697473536KUC05PN | 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 4125a395-f2a2-4467-87cf-d33d120a24f0 61 fields · synced Oct 5, 2026
- EUDAMED f79712f0-50c9-4fe7-93ad-2c7003ed66f8 61 fields · synced May 18, 2026
- EUDAMED c420f81f-cc17-4672-a95b-ffea5e973f44 61 fields · synced May 18, 2026
- EUDAMED e9692657-a555-46d2-b701-6381816f719d 61 fields · synced May 19, 2026