Identity
- Trade Name
- AFP IRMA KIT EUDAMED
- Device Name
- AFP IRMA KIT EUDAMED
- Model / Reference
- Immunoassay IM1441 EUDAMEDIM1441 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590214661 EUDAMED
- Basic UDI-DI
- 150995905AFPIRMAN4 EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class C 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
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Afp Irma Kit by IMMUNOTECH s.r.o. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 150995905AFPIRMAN4 | Class C | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (1)
- EUDAMED f3214498-3bb4-4e49-bb18-9bcfc2cedf9e 61 fields · synced Jul 15, 2026