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: Apto® F01 Full Face Mask, Class I Ventilator Accessories, Everyware, Heated Patient Circuits, PC Software.
Among these devices, 64 are declared active, 9 with a measuring function.
Devices declared under this manufacturer
- 12 / 24 V Converter (Vivo 55/65)
- Accessory Box Vivo 1-2-3
- Apto® F01 Full Face Mask Medium
- Click-On Battery, Vivo 50/60 Series
- EveryWare by Breas (v1.x.x)
- EveryWare by Breas (v3.x.x)
- Lightweight Mobility Bag Vivo 1-2-3
- Nurse call NC ODU cable
- PtcCO2 cable Sentec
- Remote Start/Stop (Vivo 45/Nippy 4)
- Remote Start/Stop Vivo 65
- Single Patient Breathing Hose
Showing 12 of 91 declared devices.
Catalogue references include 004465, 004901, 006179, 007000, 007380, 009973.
European nomenclature codes declared: Z1203019080, R02010199, Z12030103, Z1203019082, R0301010201,R0301010202, R020107.
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 |
Device-level evidence
| Devices with a numeric GTIN | 91 |
|---|---|
| Found in the U.S. device database | 53 |
| Share | 58.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BREAS MEDICAL AB |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| Class 3 devices | 4 |
| First licensed | 2014-07-25 |
Licence types: System (6), Device Family (2).
Licensed under: CLEARO, Z2 AUTO CPAP SYSTEM, VIVO 45 LS, VIVO 1, VIVO 2, VIVO 3.
North American profile: Both markets. Breas Medical AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 727515 | reissued | 2031-06-09 |