Identity
- Device Name
- PSA-RIACT EUDAMED
- Model / Reference
- PSA-RIACT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770024321302 EUDAMED
- Basic UDI-DI
- B-03770024321302 EUDAMED
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Psa-Riact by Cisbio Bioassays — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03770024321302 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Cisbio Bioassays
- EUDAMED SRN
- FR-MF-000024051
Sources (1)
- EUDAMED a7e095dc-8c49-4d44-a3be-220f0319bfdc 61 fields · synced Jul 9, 2026