IT-V Medizintechnik GmbH
AT-MF-000001918 · Austria · Innsbruck
IT-V Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 132 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 132 |
|---|
Most frequent device types declared: BellySTEP Systems, MouthBITE.
Among these devices, 8 are declared reusable, 8 active.
Devices declared under this manufacturer
- BreastSTEP Comfort Module long
- FeetSTEP Carbon
- Flexcoil Comfort Module VR
- FoamSTEP Wedge 270 x 250 x 60 to 10
- HeadSTEP Upper Plate for WingSTEP
- KneeSTEP Elevation Block M
- MCT Wedge Indexing Bar for Elekta
- MR STEP Siemens Standard
- Slide Stop PC MR
- System BreastSTEP indexed short
- System BreastSTEP indexed short MR
- System HeadSTEP IMRT
Showing 12 of 132 declared devices.
Catalogue references include P10107-183, P10107-459, P10107-518, P10107-522, P10107-584, P10107-662.
European nomenclature codes declared: Z12011280, Z12011299, Z11039085, Z11039080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ITV Medizintechnik GmbH (AT) · FDA 3007165183 |
| Devices in EUDAMED | 132 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 132 |
|---|---|
| Found in the U.S. device database | 122 |
| Share | 92.4 % |
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. IT-V Medizintechnik GmbH is registered in the United States but was not found in the Canadian register.