STAAR Surgical AG
CH-MF-000039544 · Switzerland · Nidau
STAAR Surgical AG is registered in the European database on medical devices as a manufacturer, with 4 854 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 4 847 |
|---|---|
| Class IIa | 7 |
Among these devices, 4 852 are declared sterile, 4 847 implantable, 6 reusable.
Authorised representative in the Union: STAAR Surgical AG.
Devices declared under this manufacturer
- EVO Visian ICL
- EVO Visian Toric ICL
- EVO Viva ICL
- EVO+ Visian ICL
- EVO+ Visian Toric ICL
- ICL/TICL Calculation / Implantation Orientation Diagram (IOD) Software
- MicroSTAAR
- P030101030399
- VTICMO 13.2
- Visian ICL
- Visian Toric ICL
- xEVO Visian Toric ICL
Showing 12 of 4 854 declared devices.
Catalogue references include VICM6 12.1, VICMO 13.7, VTICH 11.6, VTICH 12.1, VTICM5 12.1, VTICMO 12.1.
European nomenclature codes declared: P030101030399, P030101030199, P030101030299, P0380, Z12129082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STAAR SURGICAL AG (CH) · FDA 9614429 |
| Devices in EUDAMED | 4 854 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 4 854 |
|---|---|
| Found in the U.S. device database | 857 |
| Share | 17.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | STAAR SURGICAL AG |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 4 devices | 2 |
| First licensed | 2001-06-26 |
Licence types: Device Family (4).
Licensed under: UV-ABSORBING COLLAMER IMPLANTABLE CONTACT LENS, VISIAN ICL/TICL ONLINE CALCULATION SOFTWARE, TORIC ICL, MICROSTAAR INJECTOR CARTRIDGE FOR INTRAOCULAR .
North American profile: Both markets. STAAR Surgical AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
3830100TD01 | amended | 2027-07-15 |
3830100CE01 | amended | 2027-07-15 |