THI Total Healthcare Innovation GmbH
AT-MF-000044495 · Austria · Feistritz im Rosental
THI Total Healthcare Innovation GmbH is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 43 |
|---|
Most frequent device types declared: ViVi® HELMET, ViVi® HELMET²⁵, ViVi® CHARGER, SP250, ViVi® BATTERY PACK HW.
Among these devices, 28 are declared sterile, 15 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 | THI TOTAL HEALTHCARE INNOVATION GMBH (AT) · FDA 3017300722 |
| Devices in EUDAMED | 43 |
| Country of registration | Austria |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000302998 | supplemented | 2030-04-14 |