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fT4 Fast Test Kit (Immunofluorescence Assay)
EUDAMEDClass IVD General (EU MDR)
Ref /Ref IF5068
Identity
- Trade Name
- fT4 Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Device Name
- fT4 Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Model / Reference
- / EUDAMEDIF5068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414702569 EUDAMED06954414724059 EUDAMED
- Basic UDI-DI
- B-06954414702569 EUDAMED695441470256HH EUDAMED
- EMDN Code
- W01020402 FREE THYROXINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Netherlands EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
New Device
No
EUDAMED
fT4 Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06954414702569 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06954414702569 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 4ee409d0-6964-4483-b43a-53f313e1d730 61 fields · synced Jul 29, 2026
- EUDAMED a8f5a782-d726-48b8-9e5c-67369a3010a6 61 fields · synced Jul 29, 2026