Identity
- Device Name
- GEN EUDAMED
- Model / Reference
- 8016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588007926551 EUDAMED
- Basic UDI-DI
- B-08588007926551 EUDAMED
- EMDN Code
- W0104080501 MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Slovakia 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
No
EUDAMED
Category: Antibacterial minimum inhibitory concentration (MIC) IVD
Gen by Diagnostics s.r.o. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08588007926551 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagnostics s.r.o.
- EUDAMED SRN
- SK-MF-000038255
Sources (1)
- EUDAMED 9c1d5ef4-7651-42c8-a108-03677f365518 61 fields · synced Jul 9, 2026