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RIDASCREEN® Clostridium difficile GDH
EUDAMEDClass B (EU MDR)
Ref C0701C01-VKRef C0701K01-VKRef CRP0704Ref C0701K02-VK
Identity
- Device Name
- RIDASCREEN® Clostridium difficile GDH EUDAMED
- Model / Reference
- C0701C01-VK EUDAMEDC0701K01-VK EUDAMEDCRP0704 EUDAMEDC0701K02-VK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049095030512 EUDAMED04049095030529 EUDAMED04049095030147 EUDAMED04049095030536 EUDAMED
- Basic UDI-DI
- 4049095C070100000JW EUDAMED
- EMDN Code
- W0105011801 C.DIFFICILE GDH 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 GDH 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 | 4049095C070100000JW | Class B | Active |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (4)
- EUDAMED ad4f69e5-7ba8-4024-9b1b-50dc151d3919 61 fields · synced Oct 6, 2026
- EUDAMED f1f2954d-ea57-40a1-aeef-7a23a815fb6b 61 fields · synced May 16, 2026
- EUDAMED 3f72047e-9782-4aac-aeac-fe47e8685dff 61 fields · synced May 17, 2026
- EUDAMED 9af20fc7-5838-4a32-9fdc-42d6a445072f 61 fields · synced May 17, 2026