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STANDARD™ M10 C. difficile BT
EUDAMEDClass B (EU MDR)
Ref 11CDC20AModel M10-CBT-01
Identity
- Trade Name
- STANDARD™ M10 C. difficile BT EUDAMED
- Device Name
- STANDARD™ M10 C. difficile BT EUDAMED
- Model / Reference
- M10-CBT-01 EUDAMED11CDC20A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800111723117 EUDAMED
- Basic UDI-DI
- 88001117IPBA01MA05WV EUDAMED
- EMDN Code
- W0105011804 C.DIFFICILE BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
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
STANDARD™ M10 C. difficile BT by SD Biosensor Inc. — 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 | 88001117IPBA01MA05WV | Class B | Active |
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Manufacturer
- Manufacturer
- SD Biosensor Inc.
- EUDAMED SRN
- KR-MF-000009168
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 749536cb-868c-476e-bc00-c09bf958c3bd 61 fields · synced Jul 13, 2026