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KEYU Transferrin Rapid Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref TF-R-FRef TF-R-G
Identity
- Trade Name
- KEYU Transferrin Rapid Test (Colloidal Gold) EUDAMED
- Device Name
- Transferrin Rapid Test (Colloidal Gold) EUDAMED
- Model / Reference
- TF-R-F EUDAMEDTF-R-G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360873 EUDAMED06974735360200 EUDAMED
- Basic UDI-DI
- B-06974735360873 EUDAMEDB-06974735360200 EUDAMED
- EMDN Code
- W0102010307 TRANSFERRIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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 Transferrin Rapid Test (Colloidal Gold) 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-06974735360873 | 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 2485bfcf-1cc3-4461-82bd-5e5ade500f69 61 fields · synced Oct 1, 2026
- EUDAMED 7ab6f8e2-386d-418c-b2d1-4c5a1ac9dd10 61 fields · synced May 16, 2026