Breas Medical Limited
GB-MF-000003511 · United Kingdom · Stratford-upon-Avon
Breas Medical Limited is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 7 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: Catheter Mount Assembly with B&D exhalation port, Clearway 2, Clearway 2 Class I Accessories, Clearway 22mm IPPB circuit supplied with mouthpiece & nose-clip, NIPPY 3 22mm Disposable Breathing Circuits for Nasal & Full Mask.
Among these devices, 3 are declared active, 2 with a measuring function.
Authorised representative in the Union: Breas Medical AB.
Devices declared under this manufacturer
- Catheter Mount Assembly with Exhalation Port 22mmF to 15mmF
- Clearway 2
- Clearway 2 Cough circuit
- Clearway 2 IPPB and NIV circuit
- Clearway 2 Internal Battery
- DISPOSABLE 22MM BREATHING CIRCUIT FOR USE WITH NIPPY + VENTILATOR IN I
- DISPOSABLE 22MM BREATHING CIRCUIT FOR USE WITH NIPPY + VENTILATORS & V
- DISPOSABLE NIPPY CLEARWAY IPPB CIRCUIT
Catalogue references include 008024, 008033, 008120, 008185, 008276, 008277.
European nomenclature codes declared: R02010199, R020106, Z12159009, Z12159080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Breas Medical Ltd (GB) · FDA 3020562909 |
| Devices in EUDAMED | 9 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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 Limited is registered in both the United States and Canada.