Identity
- Trade Name
- QuickMIC Analyst EUDAMED
- Device Name
- QuickMIC Analyst EUDAMED
- Model / Reference
- 41-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350144650023 EUDAMED
- Basic UDI-DI
- 735014465GT0388 EUDAMED
- Direct Marketing DI
- 07350144650023 EUDAMED
- EMDN Code
- W0203010192 ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software 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
No
EUDAMED
New Device
No
EUDAMED
QuickMIC Analyst by Gradientech AB — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 735014465GT0388 | Class A | Active |
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Manufacturer
- Manufacturer
- Gradientech AB
- EUDAMED SRN
- SE-MF-000017760
Sources (1)
- EUDAMED 14de5efa-6f0f-40d8-a58d-e464995fc32f 61 fields · synced Jul 29, 2026