← Back to catalogue
Strep A Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref 800060RH-20P-MYModel 800060-xP
by PRIMA Lab SA
Identity
- Device Name
- STREP A RAPID TEST EUDAMED
- Model / Reference
- 800060-xP EUDAMED800060RH-20P-MY EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-800060-20PZT EUDAMED
- Basic UDI-DI
- B-800060-20PZT EUDAMED
- EMDN Code
- W01021111 ANTI-STREPTOCOCCAL SCREENING EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Strep A Rapid Test by PRIMA Lab SA — Class IVD General — 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-800060-20PZT | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PRIMA Lab SA
- EUDAMED SRN
- CH-MF-000034473
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 63013909-60f6-423e-8a62-e2a872dc11bc 61 fields · synced Jun 19, 2026