Oertli Instrumente AG
CH-MF-000016175 · Switzerland · Berneck
Oertli Instrumente AG is registered in the European database on medical devices as a manufacturer, with 145 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 122 |
|---|---|
| Class IIb | 23 |
Most frequent device types declared: MD0105.12 Surgery Packs Faros CataRhex Family Single Use, MD0105.123 I/A Tips Reusable, MD0105.13 Surgery Packs OS4 Single Use, MD0105.17 Vitrectomy Packs OS4 Single Use, MD0105.22 Sleeves Single Use.
Among these devices, 91 are declared sterile, 15 reusable, 23 active.
Authorised representative in the Union: Oertli Ophthalmedic Österreich GmbH.
Devices declared under this manufacturer
- Caliburn trocar system 25G
- CataRhex 3 easy
- Continuous Flow Cutter 23G
- Endo illuminator 25G
- I/A Quick Tip for use with irrigation sleeve 2.8mm
- I/A Quick Tip for use without irrigation sleeve, 2.8mm
- Phaco pack Faros/CR3/Swisstech, 2.2 MM
- Phaco pack OS 4, 2.2mm
- Phaco set CO-MICS
- Phaco tip easyTip CO-MICS
- SPS cutter 23G
- Single trocar with incision knife 25G
Showing 12 of 145 declared devices.
Catalogue references include VC821100CE, VV00004, VV106110, VV125311, VV125312, VV621011DEC.
European nomenclature codes declared: Q020699, Q020499, Q020601, Q020499,Q020699, Q020402, Z1212020799.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OERTLI INSTRUMENTE AG (CH) · FDA 8030967 |
| Devices in EUDAMED | 145 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 145 |
|---|---|
| Found in the U.S. device database | 53 |
| Share | 36.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OERTLI INSTRUMENTE AG |
North American profile: Both markets. Oertli Instrumente AG is registered in both the United States and Canada.