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RIDA®Quick C. difficile GDH Toxin A/B Combi
EUDAMEDClass B (EU MDR)
Ref N0823Ref NP0824
Identity
- Device Name
- RIDA®Quick C. difficile GDH Toxin A/B Combi EUDAMED
- Model / Reference
- N0823 EUDAMEDNP0824 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095140631 EUDAMED04049095140648 EUDAMED
- Basic UDI-DI
- 4049095N082300000XC EUDAMED
- EMDN Code
- W0105090106 CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC 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®Quick C. difficile GDH Toxin A/B Combi 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 | 4049095N082300000XC | Class B | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (2)
- EUDAMED 25715ff0-e172-4ebd-9983-b55f4c098e76 61 fields · synced Aug 4, 2026
- EUDAMED 52fc262e-e39c-4413-a790-2dcfbca6a715 61 fields · synced May 18, 2026