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GenomEra SARS-CoV-2 Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref CDX-130-01-20Model CDX-130Ref CDX-130-01-40
by Uniogen Oy
Identity
- Trade Name
- GenomEra SARS-CoV-2 Assay Kit EUDAMED
- Model / Reference
- CDX-130 EUDAMEDCDX-130-01-20 EUDAMEDCDX-130-01-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CDX-130-01-20UK7 EUDAMEDD-CDX-130-01-40UKH EUDAMED
- Basic UDI-DI
- B-CDX-130-01-20UK7 EUDAMEDB-CDX-130-01-40UKH EUDAMED
- EMDN Code
- W0105040519 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 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European Union No Longer Active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| EUDAMED | European Union | CE/IVDD | B-CDX-130-01-20UK7 | Class IVD General | No Longer Active |
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Manufacturer
- Manufacturer
- Uniogen Oy
- EUDAMED SRN
- FI-MF-000032341
Sources (2)
- EUDAMED 66a7d02e-4885-4a2d-a1e2-6d7e9d3de19e 61 fields · synced Jul 19, 2026
- EUDAMED f7956a22-d3eb-4e98-a513-ef6fd7dd6038 61 fields · synced May 17, 2026