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GenomEra C. difficile Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref CDX-40-02-40Model CDX-40Ref CDX-40-01-20
by Uniogen Oy
Identity
- Trade Name
- GenomEra C. difficile Assay Kit EUDAMED
- Model / Reference
- CDX-40 EUDAMEDCDX-40-02-40 EUDAMEDCDX-40-01-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CDX-40-02-40UPG EUDAMEDD-CDX-40-01-20UNT EUDAMED
- Basic UDI-DI
- B-CDX-40-02-40UPG EUDAMEDB-CDX-40-01-20UNT EUDAMED
- EMDN Code
- W0105011804 C.DIFFICILE BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
GenomEra C. difficile Assay Kit by Uniogen Oy — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-CDX-40-02-40UPG | Class IVD General | No Longer Active |
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Manufacturer
- Manufacturer
- Uniogen Oy
- EUDAMED SRN
- FI-MF-000032341
Sources (2)
- EUDAMED a799379c-f43b-460c-bea4-a49e47e0e8c4 61 fields · synced Jul 8, 2026
- EUDAMED 91bf4880-256f-4e12-8c76-6501a636d9aa 61 fields · synced May 18, 2026