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GenomEra CDX System
EUDAMEDClass A (EU MDR)
Ref CDX-10-020Model CDX-10
by Uniogen Oy
Identity
- Trade Name
- GenomEra CDX System EUDAMED
- Device Name
- GenomEra CDX System EUDAMED
- Model / Reference
- CDX-10 EUDAMEDCDX-10-020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438556100204 EUDAMED
- Basic UDI-DI
- 6438556CDX-10RB EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
GenomEra CDX System by Uniogen Oy — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438556CDX-10RB | Class A | No Longer Active |
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Manufacturer
- Manufacturer
- Uniogen Oy
- EUDAMED SRN
- FI-MF-000032341
Sources (1)
- EUDAMED 656ebb87-f20d-49a0-a7e8-40dc33f310c9 61 fields · synced Jun 18, 2026