Identity
- Trade Name
- PSA total IRMA KIT EUDAMED
- Device Name
- PSA total IRMA KIT EUDAMED
- Model / Reference
- Immunoassay IM1950 EUDAMEDIM1950 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590216207 EUDAMED
- Basic UDI-DI
- 150995905IM19506A EUDAMED
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN 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
PSA total IRMA KIT 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 | 150995905IM19506A | Class C | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (1)
- EUDAMED a9b00b22-0bdc-493c-83ac-7c4831229b56 61 fields · synced Jul 16, 2026