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KEYU Transferrin Diagnostic Kit (colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref TF-IRef TF-IIIRef TF-II
Identity
- Trade Name
- KEYU Transferrin Diagnostic Kit (colloidal gold method) EUDAMED
- Device Name
- Transferrin Diagnostic Kit(colloidal gold method) EUDAMED
- Model / Reference
- TF-I EUDAMEDTF-III EUDAMEDTF-II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360804 EUDAMED06974735360668 EUDAMED06974735360385 EUDAMED
- Basic UDI-DI
- B-06974735360804 EUDAMEDB-06974735360668 EUDAMEDB-06974735360385 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 Diagnostic Kit (colloidal gold method) 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-06974735360804 | Class IVD General | 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 e4c63f43-2e2c-4221-9c90-a2aaf0d08de7 61 fields · synced Oct 6, 2026
- EUDAMED 8a5ee8aa-f2ed-4870-9ccc-fff763fb2299 61 fields · synced May 17, 2026
- EUDAMED fee61faf-9f29-4ad3-899a-56136154693d 61 fields · synced May 17, 2026