Identity
- Trade Name
- QuickMIC Prep Kit EUDAMED
- Device Name
- QuickMIC Prep Kit EUDAMED
- Model / Reference
- 46-001-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350144650047 EUDAMED
- Basic UDI-DI
- 735014465GT0286 EUDAMED
- EMDN Code
- W0104080113 OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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 Prep Kit 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 | 735014465GT0286 | Class A | Active |
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Manufacturer
- Manufacturer
- Gradientech AB
- EUDAMED SRN
- SE-MF-000017760
Sources (1)
- EUDAMED daae6859-833d-482f-bbda-b561495362e7 61 fields · synced Jul 9, 2026