Breas Medical AB
SE-MF-000001061 · Sweden · MÖLNLYCKE
Breas Medical AB is registered in the European database on medical devices as a manufacturer, with 91 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 75 |
|---|---|
| Class IIb | 16 |
Most frequent device types declared: Class I Ventilator Accessories, Patient circuits (Non-heated), Patient circuits, Heated Patient Circuits, Everyware .
Among these devices, 64 are declared active, 9 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Breas Medical Ltd (GB) · FDA 3020562909 |
| Devices in EUDAMED | 91 |
| Country of registration | Sweden |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 727515 | reissued | 2031-06-09 |