Identity
- Trade Name
- QuickMIC GN EUDAMED
- Device Name
- QuickMIC GN EUDAMED
- Model / Reference
- 43-001-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350144650030 EUDAMED
- Basic UDI-DI
- 735014465GT048A EUDAMED
- EMDN Code
- W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Finland 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General-microorganism antimicrobial susceptibility culture medium IVD
QuickMIC GN by Gradientech AB — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-microorganism antimicrobial susceptibility culture medium IVD.
- VITEK® 2 AST-N416 — Biomérieux · Class B
- REMEL — REMEL, INC. · Class I
- VITEK® 2 AST-N457 — Biomérieux · Class B
- REMEL — REMEL, INC. · Class I
- VITEK® 2 AST-N815 — BIOMERIEUX , INC. · Class II
- REMEL — REMEL, INC. · Class I
- MicroScan — Beckman Coulter, Inc. · Class I
- MicroScan — Beckman Coulter, Inc. · Class I
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 | 735014465GT048A | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gradientech AB
- EUDAMED SRN
- SE-MF-000017760
Sources (1)
- EUDAMED 1b1819d2-c6e1-431f-8815-109402bb20af 61 fields · synced Jul 27, 2026