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.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |