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GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref CDX-160-01-100Model CDX-160Ref CDX-160-01-20
by Uniogen Oy
Identity
- Trade Name
- GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit EUDAMED
- Model / Reference
- CDX-160 EUDAMEDCDX-160-01-100 EUDAMEDCDX-160-01-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CDX-160-01-100UGV EUDAMEDD-CDX-160-01-20UMC EUDAMED
- Basic UDI-DI
- B-CDX-160-01-100UGV EUDAMEDB-CDX-160-01-20UMC EUDAMED
- EMDN Code
- W0105070302 OTHER VIRUS COMBINATIONS - MULTIPLEX 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 SARS-CoV-2, Flu A/B + RSV 2.0 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European Union No Longer Active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| EUDAMED | European Union | CE/IVDD | B-CDX-160-01-100UGV | Class IVD General | No Longer Active |
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Manufacturer
- Manufacturer
- Uniogen Oy
- EUDAMED SRN
- FI-MF-000032341
Sources (2)
- EUDAMED 6a53684b-2804-4485-ae0d-fd728420e21d 61 fields · synced Jul 30, 2026
- EUDAMED 4a8c4f9b-1503-40ea-a064-0bfe84927329 61 fields · synced May 17, 2026