B.Well Swiss AG
CH-MF-000012588 · Switzerland · Widnau
B.Well Swiss AG is registered in the European database on medical devices as a manufacturer, with 54 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 54 |
|---|
Most frequent device types declared: MED-120, PRO-110, PRO-115, TH-130, MED-111, MED-130, PRO-100, PRO-101, MED-53, MED-55, MED-50, MED-51, MED-56, MED-58, MED-80, MED-81, MED-88, MED-61, MED-62, MED-63, PRO-60, PRO-30, PRO-33, PRO-35, PRO-36, PRO-22, PRO-25, PRO-26, TH-71, TH-73, MED-53 G.
Among these devices, 44 are declared active, 40 with a measuring function.
Authorised representative in the Union: Blue Broccoli GmbH.
Devices declared under this manufacturer
- MED-111 Compressor nebulizer
- MED-120 Compressor nebulizer
- MED-53 Automatic blood pressure monitor
- MED-63 Aneroid Blood Pressure Kit
- PRO-06 Digital Thermometer
- PRO-110 Medical nebulizer
- PRO-115 Medical nebulizer
- PRO-25 Automatic blood pressure monitor
- PRO-30 Semi-automatic blood pressure monitor
- TH-75 Automatic blood pressure monitor
- WC-150
- WS-1 Single Head Stethoscope
Showing 12 of 54 declared devices.
Catalogue references include 1101218, 1101222, 1101309, 1101371, 1101379, 1101388.
European nomenclature codes declared: Z1203020302, V0301010201, C9005, Z12159002, V0301010202, C9006.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 54 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 54 |
|---|---|
| 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: Neither register. B.Well Swiss AG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44911220852 | supplemented | 2029-11-12 |