Optima Medical Swiss AG
CH-MF-000041543 · Switzerland · Zug
Optima Medical Swiss AG is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 16 |
|---|---|
| Class IIb | 13 |
Most frequent device types declared: TD OM 02, TD OM 05, TD OM 06, TD OM 07, TD OM 09.
Among these devices, 17 are declared sterile.
Authorised representative in the Union: Optima Sanità S.r.l..
Devices declared under this manufacturer
- Hyaluron-ratiopharm Augentropfen
- Hyaluron-ratiopharm Gel Augentropfen
- Lipo Nit Augentropfen
- LipoAerosol
- LipoNasal
- M-Club Dry Eye Drops
- OccuniX
- Optrex ACTIMIST
- Optrex ACTISPRAY
- apo discounter Hyaluron 0,3% Augentropfen Gel
- apo discounter Hyaluron 0,3% Dexpanthenol Augentropfen
- apo discounter Hyaluron 0.1% Augentropfen
Showing 12 of 29 declared devices.
Catalogue references include 310050, 310051, 600102, 600116, 600119, 600120.
European nomenclature codes declared: Q0299, R0699, Q030103.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 29 |
| 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 | 16 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OPTIMA MEDICAL SWISS AG |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2016-08-09 |
Licence types: Single Device (1).
Licensed under: CALMO EYE SPRAY.
North American profile: Canada only. Optima Medical Swiss AG holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
7086GB448260225 | supplemented | 2028-10-17 |