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Strep A Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 800060-x
by PRIMA Lab SA
Identity
- Device Name
- STREP A TEST EUDAMED
- Model / Reference
- 800060-x EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CH-MF-000034473JT EUDAMED
- Basic UDI-DI
- B-CH-MF-000034473JT EUDAMED
- EMDN Code
- W01021111 ANTI-STREPTOCOCCAL SCREENING EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Strep A Test by PRIMA Lab SA — Class IVD devices for self-testing — 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-CH-MF-000034473JT | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- PRIMA Lab SA
- EUDAMED SRN
- CH-MF-000034473
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED fd34b5d1-31de-4542-8fb5-3fc773fb66bc 61 fields · synced Jun 18, 2026