Identity
- Trade Name
- Working solution eCMA MITO EUDAMED
- Device Name
- Working solution eCMA MITO EUDAMED
- Model / Reference
- NOX-22.1-VIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-eCMAMITO6Y EUDAMED
- Basic UDI-DI
- B-eCMAMITO6Y EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Working solution eCMA MITO by Noxygen Science Transfer & Diagnostics GmbH — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-eCMAMITO6Y | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Noxygen Science Transfer & Diagnostics GmbH
- EUDAMED SRN
- DE-MF-000024761
Sources (1)
- EUDAMED 57abff2e-55d6-4a81-bb89-a928254dea96 61 fields · synced Jun 19, 2026