← Back to catalogue
GenomEra GBS Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref CDX-60-01-20Model CDX-60
by Uniogen Oy
Identity
- Trade Name
- GenomEra GBS Assay Kit EUDAMED
- Model / Reference
- CDX-60 EUDAMEDCDX-60-01-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CDX-60-01-20UQ9 EUDAMED
- Basic UDI-DI
- B-CDX-60-01-20UQ9 EUDAMED
- EMDN Code
- W0105011102 STREPTOCOCCAL DETECTION 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 GBS 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European Union No Longer Active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| EUDAMED | European Union | CE/IVDD | B-CDX-60-01-20UQ9 | Class IVD General | No Longer Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Uniogen Oy
- EUDAMED SRN
- FI-MF-000032341
Sources (1)
- EUDAMED c79a2f3a-e71f-4564-95a3-b4e96244968f 61 fields · synced Jun 20, 2026