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Sign in to claim this brandTHI TOTAL HEALTHCARE INNOVATION GMBH
Austria·AT-MF-000044495
Last updated September 17, 2026
What THI TOTAL HEALTHCARE INNOVATION GMBH makes
This manufacturer produces disposable and reusable protective systems for surgical and medical environments, including single-use and premium-grade togas, battery-powered togas, and pull-over designs. Their portfolio also includes surgical helmet systems, hoods, and high-performance helmet variants designed for extended use in sterile procedures. These products are intended for use in operating rooms, sterile fields, and other controlled medical settings to maintain hygiene and reduce contamination risks.
The company’s devices are classified under EU Medical Device Regulations as Class I and Class II, with listings in the EUDAMED database and FDA’s 510(k) registry. Their products are also subject to compliance with relevant EU directives and FDA requirements, ensuring adherence to regulatory standards for medical devices. The manufacturer is based in Austria.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does THI Total Healthcare Innovation GmbH manufacture?
THI Total Healthcare Innovation GmbH specializes in protective systems for surgical and medical environments. Their portfolio includes disposable and reusable togas (such as single-use, battery-powered, and premium-grade variants), pull-over designs, surgical helmet systems (including standard and high-performance variants like ViVi® Helmet²⁵ HPL), and hoods. These devices are designed for use in operating rooms, sterile fields, and controlled medical settings to enhance hygiene and minimize contamination risks.
Where is THI Total Healthcare Innovation GmbH based?
The company is headquartered in Austria, as indicated by its regulatory listings and device classifications under EU Medical Device Regulations.
Which regulatory registries list THI Total Healthcare Innovation GmbH’s devices?
THI Total Healthcare Innovation GmbH’s devices are listed in the EUDAMED database (for EU compliance) and the FDA’s 510(k) registry (for US clearance). These registries reflect their adherence to EU Medical Device Regulations and FDA requirements, ensuring their products meet applicable regulatory standards.
How are THI Total Healthcare Innovation GmbH’s devices classified under EU regulations?
The company’s devices are classified under the EU Medical Device Regulations as Class I (typically low-risk, non-invasive items like some protective garments) and Class II (moderate-risk devices, such as certain helmet systems or reusable components requiring additional safety measures). Classification depends on factors like intended use, risk of harm, and design complexity, as outlined in EU MDR Annex VIII.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Austria
- Address
- 4, Gewerbestrasse, Feistritz im Rosental, Austria
- Website
- www.thigmbh.at/
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Karl Hintermann
- EUDAMED SRN
- AT-MF-000044495
- FDA FEI Number
- 3017300722
- DUNS Number
- —
Catalogue (35)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ViVi® TOGA SIZE XXS-S | 80222V | EUDAMED | Class I | Active |
| ViVi® TOGA SIZE M-L | 80221V | EUDAMED | Class I | Active |
| ViVi® TOGA PREMIUM M-L | 82221 | EUDAMEDFDA UDI | Class I | Active |
| ViVi® BATTERY PACK HW | 60402 | EUDAMED | Class I | Active |
| ViVi® TOGA PREMIUM XL-XXL | 82220 | EUDAMEDFDA UDI | Class I | Active |
| ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | K222214 | FDA 510(k) | Class II | Active |
| ViVi® HELMET²⁵ HPL | 81130 | EUDAMED | Class I | Active |
| ViVi® HELMET | 80100 Rev-S4 | EUDAMEDFDA UDI | Class I | Active |
| ViVi® TOGA PREMIUM XXS-S | 82222 | EUDAMEDFDA UDI | Class I | Active |
| ViVi® PULL-OVER TOGA SIZE M-L | 80231V | EUDAMED | Class I | Active |
| ViVi® HOOD | 80200V | EUDAMEDFDA UDI | Class I | Active |
| ViVi® HELMET²⁵ | 81100 | EUDAMED | Class I | Active |
| ViVi® TOGA PREMIUM 3XL | 82223V | EUDAMED | Class I | Active |
| SPS - Sterile Protection Shield | SP250 | EUDAMED | Class I | Active |
| ViVi® PULL-OVER TOGA SIZE XXS-S | 80232 | EUDAMED | Class I | Active |
| ViVi® TOGA SIZE M-L | 80221 | EUDAMED | Class I | Active |
| ViVi® HELMET | 80100 | EUDAMEDFDA UDI | Class I | Active |
| ViVi® HELMET | 80100 Rev-S3 | EUDAMED | Class I | Active |
| ViVi® TOGA SIZE XXL-XL | 80220V | EUDAMED | Class I | Active |
| ViVi® HELMET²⁵ XL | 81100XL | EUDAMED | Class I | Active |
| ViVi® FOUR-BAY CHARGER | 60504 | EUDAMED | Class I | Active |
| ViVi® PEEL-OFF HOOD | 80500 | EUDAMEDFDA UDI | Class I | Active |
| ViVi® HOOD | 80210 | EUDAMED | Class I | Active |
| ViVi® TOGA PREMIUM XXS-S | 82222V | EUDAMEDFDA UDI | Class I | Active |
| ViVi® HELMET HPL | 80130 Rev-S3 | EUDAMED | Class I | Active |
| ViVi® PULL-OVER TOGA SIZE M-L | 80231 | EUDAMED | Class I | Active |
| ViVi® TOGA PREMIUM M-L | 82221V | EUDAMEDFDA UDI | Class I | Active |
| ViVi® SINGLE-BAY SMART CHARGER | 60501 | EUDAMED | Class I | Active |
| ViVi® TOGA SIZE XXS-S | 80222 | EUDAMED | Class I | Active |
| ViVi® FOUR-BAY PRIO CHARGER | 60506 | EUDAMED | Class I | Active |
| ViVi® BATTERY HOLSTER HW - JP | 60403JP | EUDAMED | Class I | Active |
| ViVi® TOGA PREMIUM XL-XXL | 82220V | EUDAMEDFDA UDI | Class I | Active |
| ViVi® PULL-OVER TOGA SIZE XL-XXL | 80230 | EUDAMED | Class I | Active |
| ViVi® HOOD HFD | 80301 | EUDAMED | Class I | Active |
| ViVi® HELMET²⁵ XL HPL | 81130XL | EUDAMED | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- THI Total Healthcare Innovation GmbH US