Identity
- Device Name
- RIDA®Prime H. pylori BDM EUDAMED
- Model / Reference
- PM2305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095161742 EUDAMED
- Basic UDI-DI
- 4049095PM23050000JU EUDAMED
- EMDN Code
- W0105010403 H. PYLORI DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class B 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
New Device
No
EUDAMED
RIDA®Prime H. pylori BDM by R-Biopharm AG — Class B — 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 | 4049095PM23050000JU | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (1)
- EUDAMED 6f451559-6307-4e19-8878-c1e558510d51 61 fields · synced Jul 11, 2026