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Toxigenic Clostridium difficile Gene (toxinA, toxinB) Detection Kit (PCR Fluore…
EUDAMEDClass IVD General (EU MDR)
Ref 106-0159-01Model 12 reactions/kit
Identity
- Device Name
- Toxigenic Clostridium difficile Gene (toxinA, toxinB) Detection Kit (PCR Fluorescence ) EUDAMED
- Model / Reference
- 12 reactions/kit EUDAMED106-0159-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975447582256 EUDAMED
- Basic UDI-DI
- B-06975447582256 EUDAMED
- EMDN Code
- W0105011804 C.DIFFICILE BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Toxigenic Clostridium difficile Gene (toxinA, toxinB) Detection Kit (PCR Fluore… by Igenesis(Shanghai)Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975447582256 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Igenesis(Shanghai)Co., Ltd.
- EUDAMED SRN
- CN-MF-000001552
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 5694d96b-f42c-42db-8fab-6075a9229a56 61 fields · synced Jul 22, 2026