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FT4 Plus RIA KIT
EUDAMEDClass B (EU MDR)
Ref C55857Model Immunoassay, C55856, C55857Ref C55856
Identity
- Trade Name
- FT4 Plus RIA KIT EUDAMED
- Device Name
- FT4 Plus RIA KIT EUDAMED
- Model / Reference
- Immunoassay, C55856, C55857 EUDAMEDC55857 EUDAMEDC55856 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590774172 EUDAMED15099590774165 EUDAMED
- Basic UDI-DI
- 150995905FT4PlusY3 EUDAMED
- EMDN Code
- W01020402 FREE THYROXINE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
FT4 Plus RIA KIT by IMMUNOTECH s.r.o. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995905FT4PlusY3 | Class B | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (2)
- EUDAMED 7e5c127d-64d2-4d0f-b20a-56098de44ae3 61 fields · synced Jul 18, 2026
- EUDAMED 24c6d3c6-042d-4c57-97cf-0063fa203114 61 fields · synced May 16, 2026