Identity
- Device Name
- RIDASCREEN® Clostridium difficile Toxin A/B EUDAMED
- Model / Reference
- C0801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095030017 EUDAMED
- Basic UDI-DI
- 4049095C080100000KH EUDAMED
- EMDN Code
- W0105011802 C.DIFFICILE TOXIN A/B DETECTION 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
RIDASCREEN® Clostridium difficile Toxin A/B 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 | 4049095C080100000KH | Class B | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (1)
- EUDAMED 53b312cc-3532-4787-bb14-9f52326a1bfc 61 fields · synced Jun 19, 2026