Carl Zeiss Vision GmbH
DE-MF-000006173 · Germany · Aalen
Carl Zeiss Vision GmbH is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: 000000-2069-910, 000000-2120-340, 000000-2194-446, 000000-2265-586, 000000-2351-293.
Among these devices, 14 are declared active, 8 with a measuring function.
Devices declared under this manufacturer
- VISUCONSULT 500
- VISUCORE 500 Refractor
- VISUFIT 1000
- VISUFIT 1000 Platform
- VISUREF 600
- VISUSCREEN 100
- VISUSCREEN 100 Compact
- VISUSCREEN 500
- VISUSTAR go
- ZEISS Mobile Centration
- i.Terminal 2
- i.Terminal 2 Station
Showing 12 of 14 declared devices.
Catalogue references include 000000-2069-910, 000000-2120-340, 000000-2351-293, 000000-2408-309, 000000-2433-519, 000000-2522-536.
European nomenclature codes declared: Q0299, Z12120199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CARL ZEISS VISION GMBH (DE) · FDA 9617474 |
| Devices in EUDAMED | 14 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 12 |
| Share | 85.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CARL ZEISS VISION |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2014-01-13 |
Licence types: Single Device (3), Device Family (1).
Licensed under: I.PROFILER PLUS, ATLAS REVIEW FOR I.PROFILER PLUS, VISUCORE 500 REFRACTOR, VISUREF 600.
North American profile: Both markets. Carl Zeiss Vision GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000266776 | issued | 2026-10-27 |