Identity
- Trade Name
- ASTar BC G- Consumable kit EUDAMED
- Device Name
- ASTar BC G- Kit EUDAMED
- Model / Reference
- 50003905 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350136800023 EUDAMED
- Basic UDI-DI
- 7350136805000617965 EUDAMED
- EMDN Code
- W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Category: General-microorganism antimicrobial susceptibility culture medium IVD
ASTar BC G- Consumable kit by Q-Linea AB — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 7350136805000617965 | Class C | Active |
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Manufacturer
- Manufacturer
- Q-linea AB
- EUDAMED SRN
- SE-MF-000013026
Sources (1)
- EUDAMED 1398e11a-57fd-41b8-99e1-c5ca36ad164f 61 fields · synced Jun 18, 2026