← Back to catalogue
KEYU FOB multi-level indefinite value controls
EUDAMEDClass IVD General (EU MDR)
Ref Level Ⅲ-ⅡRef Level IV-Ⅱ
Identity
- Trade Name
- KEYU FOB multi-level indefinite value controls EUDAMED
- Device Name
- FOB multi-level indefinite value controls EUDAMED
- Model / Reference
- Level Ⅲ-Ⅱ EUDAMEDLevel IV-Ⅱ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360125 EUDAMED06974735360699 EUDAMED
- Basic UDI-DI
- B-06974735360125 EUDAMEDB-06974735360699 EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
KEYU FOB multi-level indefinite value controls by Zhuhai Keyu Biological Engineering Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974735360125 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 129d0721-554d-4b74-a208-b6d4db39c1a9 61 fields · synced Jul 10, 2026
- EUDAMED 699017e0-70ba-481a-9c2d-8429f84d1f8d 61 fields · synced Jul 10, 2026