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: SP250, ViVi® BATTERY HOLSTER HW - JP, ViVi® BATTERY PACK HW, ViVi® CHARGER, ViVi® HELMET.
Among these devices, 28 are declared sterile, 15 active.
Devices declared under this manufacturer
- SPS - Sterile Protection Shield
- ViVi® FOUR-BAY CHARGER
- ViVi® HELMET HPL
- ViVi® HELMET²⁵ HPL
- ViVi® HELMET²⁵ XL
- ViVi® HOOD
- ViVi® HOOD HFD
- ViVi® PULL-OVER TOGA SIZE XL-XXL
- ViVi® PULL-OVER TOGA SIZE XXS-S
- ViVi® TOGA PREMIUM M-L
- ViVi® TOGA PREMIUM XL-XXL
- ViVi® TOGA PREMIUM XXS-S
Showing 12 of 43 declared devices.
Catalogue references include 80130 Rev-S3, 80230, 81100XL, 81130, 82220, 82222.
European nomenclature codes declared: T020401, L0316, L0318, M03030299.
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 |
Device-level evidence
| Devices with a numeric GTIN | 43 |
|---|---|
| Found in the U.S. device database | 14 |
| Share | 32.6 % |
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. THI Total Healthcare Innovation GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000302998 | supplemented | 2030-04-14 |