Q-linea AB
SE-MF-000013026 · Sweden · Uppsala
Q-linea AB is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- ASTar BC G- Consumable kit
- ASTar BC G- Frozen insert
- ASTar BC G- Kit software CE-IVDR
- ASTar BC G- Kit software, (EUCAST)
- ASTar Instrument
Catalogue references include 50003135, 50003855, 50003905, 50005392.
European nomenclature codes declared: W0104080107, W0203010180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Q-linea AB (SE) · FDA 3027320620 |
| Devices in EUDAMED | 5 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 20.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Q-linea AB is registered in the United States but was not found in the Canadian register.