<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09009607822207</udiDi>
    <basicUdiDi>9009607GOWNS82XXXDJ</basicUdiDi>
    <tradeName>ViVi® TOGA PREMIUM XL-XXL</tradeName>
    <deviceName>ViVi® GOWNS 82XXX</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82220</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:47:21.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607811003</udiDi>
    <basicUdiDi>9009607HELMET81XXXHK</basicUdiDi>
    <tradeName>ViVi® HELMET²⁵</tradeName>
    <deviceName>ViVi® HELMET²⁵</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:47:19.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607802001</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® Hood</tradeName>
    <deviceName>ViVi® GOWNS 80XXX</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:47:19.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607801004</udiDi>
    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET</tradeName>
    <deviceName>ViVi® HELMET</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:47:17.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607605015</udiDi>
    <basicUdiDi>9009607CHARGERBLA6</basicUdiDi>
    <tradeName>ViVi® SINGLE-BAY SMART CHARGER</tradeName>
    <deviceName>ViVi® CHARGER</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0318</emdnCode>
    <emdnDescription>INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:47:15.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607604131</udiDi>
    <basicUdiDi>9009607HOLST60403WD</basicUdiDi>
    <tradeName>ViVi® BATTERY HOLSTER HW - JP</tradeName>
    <deviceName>ViVi® BATTERY HOLSTER HW - JP</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0318</emdnCode>
    <emdnDescription>INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60403JP</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:47:13.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607604025</udiDi>
    <basicUdiDi>9009607BATT60402WJ</basicUdiDi>
    <tradeName>ViVi® BATTERY PACK HW</tradeName>
    <deviceName>ViVi® BATTERY PACK HW</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0318</emdnCode>
    <emdnDescription>INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:47:12.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607002500</udiDi>
    <basicUdiDi>9009607SPSXXXAZ</basicUdiDi>
    <tradeName>SPS - Sterile Protection Shield</tradeName>
    <deviceName>SP250</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03030299</emdnCode>
    <emdnDescription>PROTECTION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP250</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:47:11.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607801035</udiDi>
    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:59:20.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607801042</udiDi>
    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:59:20.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607801301</udiDi>
    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET HPL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:59:20.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607801332</udiDi>
    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET HPL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:59:20.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607801349</udiDi>
    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET HPL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:59:20.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607811010</udiDi>
    <basicUdiDi>9009607HELMET81XXXHK</basicUdiDi>
    <tradeName>ViVi® HELMET²⁵ XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:59:12.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607811300</udiDi>
    <basicUdiDi>9009607HELMET81XXXHK</basicUdiDi>
    <tradeName>ViVi® HELMET²⁵ HPL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:59:12.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607811317</udiDi>
    <basicUdiDi>9009607HELMET81XXXHK</basicUdiDi>
    <tradeName>ViVi® HELMET²⁵ XL HPL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:59:12.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607802209</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® TOGA SIZE XL_XXL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T07:07:49.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607802216</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® TOGA SIZE M-L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T07:07:49.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607802223</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® TOGA SIZE XXS-S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T07:07:49.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>09009607802308</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® PULL-OVER TOGA SIZE XL-XXL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T07:07:49.025Z</lastUpdated>
  </row>
</eudamedExport>