Identity
- Device Name
- RIDA®GENE PVL EUDAMED
- Model / Reference
- PG0645 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095160042 EUDAMED
- Basic UDI-DI
- B-04049095160042 EUDAMED
- EMDN Code
- W0105011299 STAPHYLOCOCCI REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Rida®gene Pvl by R-Biopharm AG — 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-04049095160042 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (1)
- EUDAMED f1851573-8781-420e-9b26-7bff33143cc8 61 fields · synced Jul 18, 2026