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GenomEra Norovirus Assay kit
EUDAMEDClass IVD General (EU MDR)
Ref CDX-100-01-20Model CDX-100
by Uniogen Oy
Identity
- Trade Name
- GenomEra Norovirus Assay kit EUDAMED
- Model / Reference
- CDX-100 EUDAMEDCDX-100-01-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CDX-100-01-20UH2 EUDAMED
- Basic UDI-DI
- B-CDX-100-01-20UH2 EUDAMED
- EMDN Code
- W0105040516 NOROVIRUS - 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 Norovirus 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European Union No Longer Active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| EUDAMED | European Union | CE/IVDD | B-CDX-100-01-20UH2 | Class IVD General | No Longer Active |
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Manufacturer
- Manufacturer
- Uniogen Oy
- EUDAMED SRN
- FI-MF-000032341
Sources (1)
- EUDAMED d2d5522c-d5f5-4baa-bf0a-964d8da298f7 61 fields · synced Jun 18, 2026