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KEYU Hemoglobin Quality Control (Quantitative)
EUDAMEDClass IVD General (EU MDR)
Ref FOB-QC-4
Identity
- Trade Name
- KEYU Hemoglobin Quality Control (Quantitative) EUDAMED
- Device Name
- Hemoglobin Quality Control (Quantitative) EUDAMED
- Model / Reference
- FOB-QC-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360170 EUDAMED
- Basic UDI-DI
- B-06974735360170 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
Yes
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
KEYU Hemoglobin Quality Control (Quantitative) 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-06974735360170 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 3fa26cf6-8900-4cad-a2f6-0a3bf545b22b 61 fields · synced Oct 6, 2026
- EUDAMED 1ab71784-5441-4065-8de7-a461a1456dc5 61 fields · synced Sep 17, 2026