POWERbreathe International Limited
UK-MF-000045438 · United Kingdom · Southam
POWERbreathe International Limited is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 39 |
|---|
Among these devices, 9 are declared active.
Authorised representative in the Union: HaB GmbH.
Devices declared under this manufacturer
- Italian Pbreathe Medic 1 unit
- POWERbreathe International Limited
- POWERbreathe Plus Black HR German/Italian/French
- POWERbreathe Plus Black LR German/Italian/French
- POWERbreathe Plus Black MR German/Italian/French
- POWERbreathe Plus HR German/Italian/French
- POWERbreathe Plus LR German/Italian/French
- POWERbreathe Plus MR German/Italian/French
- Shaker Classic
- Shaker Deluxe
- Shaker Deluxe Kids
- Shaker Deluxe Light Resistance
Showing 12 of 39 declared devices.
Catalogue references include PB1002, PB2004, PB2005 G/IT, PB2006 G/IT, PB2007, PB7001.
European nomenclature codes declared: R9099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | POWERbreathe International Ltd (GB) · FDA 3003775414 |
| Devices in EUDAMED | 39 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 39 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. POWERbreathe International Limited is registered in the United States but was not found in the Canadian register.