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Sign in to claim this brandBreas Medical AB
Sweden·SE-MF-000001061
Last updated September 17, 2026
Information
- Country
- Sweden
- Address
- 1, Företagsvägen, MÖLNLYCKE, Sweden
- Website
- www.breas.com/
- —
- —
- [email protected]
- Phone
- +4631868800
- PRRC Contact
- Ivan Liljegren
- EUDAMED SRN
- SE-MF-000001061
- FDA FEI Number
- 3003244771
- DUNS Number
- 357007657
Catalogue (133)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vivo 50 | 005428 | FDA UDI | Class II | Unknown |
| Vivo 65 | 005432 | FDA UDI | Class II | Active |
| Ha01 | US | FDA UDI | Class II | Unknown |
| Vivo 50, VIvo 65 | 004909 | FDA UDI | Class II | Active |
| Vivo 50, Vivo 65 | 005066 | FDA UDI | Class II | Active |
| Breas iSleep 20i system | US | FDA UDI | Class II | Unknown |
| Vivo 50 | 004891 | FDA UDI | Class II | Active |
| Vivo 1/2, Vivo 3 | 006712 | FDA UDI | Class I | Active |
| Vivo 45 LS | 007105 | FDA UDI | Class II | Active |
| Vivo 50, VIvo 65 | 004910 | FDA UDI | Class II | Active |
| Breas iSleep 20+ system | US | FDA UDI | Class II | Unknown |
| Vivo 50 | 004893 | FDA UDI | Class II | Active |
| Vivo 50 | 005094 | FDA UDI | Class II | Active |
| Vivo 1/2, Vivo 3 | 007203 | FDA UDI | Class II | Active |
| Vivo 50, VIvo 65 | 004939 | FDA UDI | Class II | Active |
| Vivo 50, Vivo 65, Vivo 45 LS | 006708 | FDA UDI | Class II | Active |
| Vivo Series | 006093 | FDA UDI | Class I | Active |
| Vivo 50, VIvo 65 | 005189 | FDA UDI | Class II | Active |
| Vivo 65 | US | FDA UDI | Class II | Active |
| Breas iSleep 20 System | US | FDA UDI | Class II | Unknown |
| Vivo 45 LS | 006172 | FDA UDI | Class II | Active |
| Vivo 45 LS | 006710 | FDA UDI | Class II | Active |
| Vivo 50 | 005036 | FDA UDI | Class II | Active |
| GCX- Vivo 45 Series Trolley | 010472 | FDA UDI | Class I | Active |
| Breas Vivo 30 System | US | FDA UDI | Class II | Unknown |
| Vivo 45 LS | 007104 | FDA UDI | Class II | Active |
| Vivo 50 | 004897 | FDA UDI | Class II | Active |
| Vivo 45 LS | 007064 | FDA UDI | Class II | Active |
| Vivo 50 | 005928 | FDA UDI | Class II | Active |
| Vivo 50 | 004894 | FDA UDI | Class II | Active |
| Vivo 1/2, Vivo 3 | 007202 | FDA UDI | Class II | Active |
| Vivo 45 LS, Vivo 65 | 006359 | FDA UDI | Class II | Active |
| Vivo 45 LS | 006014 | FDA UDI | Class II | Active |
| Vivo 50 | 004896 | FDA UDI | Class II | Active |
| Vivo 50 | US | FDA UDI | Class II | Unknown |
| Vivo 50 | 005223 | FDA UDI | Class II | Active |
| Vivo 45 LS | 007654 | FDA UDI | Class II | Active |
| Vivo 50 | 004892 | FDA UDI | Class II | Active |
| Vivo 45 LS | 006396 | FDA UDI | Class II | Active |
| Vivo Series | 004426 | FDA UDI | Class I | Active |
| Vivo 45 LS | 007733 | FDA UDI | Class II | Active |
| Vivo 45 LS | 006711 | FDA UDI | Class II | Active |
| Vivo 50 | US | FDA UDI | Class II | Unknown |
| Vivo 50, Vivo 65 | 004886 | FDA UDI | Class II | Active |
| Vivo 45 LS | 003522 | FDA UDI | Class II | Active |
| Vivo 50, Vivo 65, Vivo 45 LS | 002185 | FDA UDI | Class II | Active |
| Vivo 50 | US | FDA UDI | Class II | Unknown |
| Vivo 30/40 PC Software | 004380 | EUDAMED | Class IIb | Active |
| Trolley IV Pole | 007859 | EUDAMEDFDA UDI | Class I | Active |
| PtcCO2 cable Radiometer TCM5 | 008392 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 25, 2024 | Z-2690-2024 | — | open, classified | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. |
| Oct 13, 2023 | Z-0405-2024 | — | open, classified | Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation |
| Jun 2, 2022 | Z-1382-2022 | — | open, classified | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained |
| Mar 21, 2022 | Z-0943-2022 | — | terminated | Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity |
| Jan 28, 2020 | Z-1352-2020 | — | terminated | The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. |
FDA Establishments (2)
Establishments registered with the FDA under this company group, matched by name.
- Breas Medical, Inc. US
- Breas Medical Limited GB