Identity
- Trade Name
- ASTar BC G- Frozen insert EUDAMED
- Device Name
- ASTar BC G- Kit EUDAMED
- Model / Reference
- 50003855 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350136800016 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
ASTar BC G- Frozen insert by Q-Linea AB — Class C — 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 | 7350136805000617965 | Class C | Active |
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Manufacturer
- Manufacturer
- Q-linea AB
- EUDAMED SRN
- SE-MF-000013026
Sources (1)
- EUDAMED eb14a08a-a2d1-455c-abb5-de50345909f7 61 fields · synced Jul 26, 2026