iSYS Medizintechnik GmbH
AT-MF-000000275 · Austria · Kitzbühel
iSYS Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 36 |
|---|
Most frequent device types declared: iONE.
Among these devices, 2 are declared active.
Devices declared under this manufacturer
- Micromate Navi+
- iFIX Canon Aquilion Adapter
- iFIX Fleece 5
- iFIX Head Mask L
- iFIX Head Mask S
- iFIX Head Mask XS
- iFIX Patch 15
- iFIX Patch 50
- iFIX Slot Adapter 10.0/30
- iFIX Slot Adapter 2.0/30
- iFIX Slot Adapter 3.0/30
- iFIX Slot Adapter 8.0/30
Showing 12 of 36 declared devices.
Catalogue references include 16192L003, 17622L003, 26103, 26105, 31618, 40289.
European nomenclature codes declared: V0804, Z12011482, Z12011401, V0880.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | iSYS Medizintechnik GmbH (DE) · FDA 3013847349 |
| Devices in EUDAMED | 36 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 36 |
|---|---|
| Found in the U.S. device database | 33 |
| Share | 91.7 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. iSYS Medizintechnik GmbH is registered in the United States but was not found in the Canadian register.