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IRMA MUC-1 gene associated antigen (CA 15-3)
EUDAMEDClass C (EU MDR)
Ref B64314Model IM2397, B64314Ref IM2397
Identity
- Trade Name
- IRMA MUC-1 gene associated antigen (CA 15-3) EUDAMED
- Device Name
- IRMA MUC-1 gene associated antigen (CA 15-3) EUDAMED
- Model / Reference
- IM2397, B64314 EUDAMEDB64314 EUDAMEDIM2397 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590666323 EUDAMED15099590217402 EUDAMED
- Basic UDI-DI
- 150995905CA15-3IRMAMG EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 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
IRMA MUC-1 gene associated antigen (CA 15-3) by IMMUNOTECH s.r.o. — Class C — 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 | 150995905CA15-3IRMAMG | Class C | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (2)
- EUDAMED 9734b405-5bd5-4a80-89c9-dc0d2a0dfdf1 61 fields · synced Jul 21, 2026
- EUDAMED 05df7686-4031-4d95-b569-2b17d97929ff 61 fields · synced May 17, 2026