Technolas Perfect Vision GmbH
DE-MF-000007094 · Germany · Munich
Technolas Perfect Vision GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 13 |
|---|---|
| Class IIa | 4 |
Among these devices, 2 are declared sterile, 14 active.
Devices declared under this manufacturer
- Adapter suction port-kit
- Patient Interface 125 Kit
- RMF UPGRADEKIT TENEO M2 SW1.28
- SeeLyra Kit
- TECHNOLAS TENEO 317 Model 2
- TECHNOLAS TENEO 317 Model 2 Remanufactured
- TECHNOLAS TENEO 317 Model2 V1
- UPGRADE KIT TENEO M2 4TH EDIT
- UPGRADE KIT TENEO M2 SW 1.30
- UPGRADE KIT TENEO M2 SW V1.31
- UPGRADE KIT TENEO MODEL2 SW1.28
- VICTUS Femtosecond Laser Platform
Showing 12 of 17 declared devices.
Catalogue references include 14679TPV, 50007021TPV, 70009803TPV, 70009804TPV, 70009806TPV, 70009807TPV.
European nomenclature codes declared: Z12011010, Z12011006, Z12011085, Z12120121, Z12011001, Z12011080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TECHNOLAS PERFECT VISION GMBH (DE) · FDA 3007606649 |
| Devices in EUDAMED | 17 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 28.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TECHNOLAS PERFECT VISION GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 2 |
| First licensed | 2013-06-17 |
Licence types: System (4).
Licensed under: VICTUS FEMTOSECOND LASER PLATFORM, ZYOPTIX DIAGNOSTIC WORKSTATION 3 (ZDW3), TENEO 317, ACE ADVANCED CORNEAL EXPLORER.
North American profile: Both markets. Technolas Perfect Vision GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1061119-1 | supplemented | 2028-07-11 |