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Transferrin/FOB/Hb-Hp Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref TFH-F32a
Identity
- Trade Name
- Transferrin/FOB/Hb-Hp Combo Rapid Test EUDAMED
- Device Name
- Transferrin/FOB/Hb-Hp Combo Rapid Test EUDAMED
- Model / Reference
- TFH-F32a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TFH-F32aHP EUDAMED
- Basic UDI-DI
- B-TFH-F32aHP EUDAMED
- EMDN Code
- W0102160999 INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER 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
Transferrin/FOB/Hb-Hp Combo Rapid Test by Hangzhou Aichek Medical Technology 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-TFH-F32aHP | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED a79ea999-40d1-4484-ae3f-3151a7554028 61 fields · synced Jul 9, 2026