Enbio Group AG
CH-MF-000054967 · Switzerland · Oensingen
Enbio Group AG is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 29 |
|---|
Most frequent device types declared: Enbio S.
Among these devices, 29 are declared active.
Authorised representative in the Union: RQS Wojciech Roman.
Catalogue references include Enbio S, Enbio S Ashy Stone, Enbio S Black, Enbio S Dolly Pink, Enbio S Gray, Enbio S ver. Beauty.
European nomenclature codes declared: Z12011305.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ENBIO GROUP AG (CH) · FDA 3016777357 |
| Devices in EUDAMED | 29 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 29 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 20.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ENBIO GROUP AG |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2026-03-30 |
Licence types: Device Family (1).
Licensed under: ENBIO S.
North American profile: Both markets. Enbio Group AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TNP/MDR/0037/4780/2025 | issued | 2028-06-15 |