<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719893347319</udiDi>
    <basicUdiDi>B-04719893347319</basicUdiDi>
    <tradeName>WiZARD 510</tradeName>
    <deviceName>Nasal Mask</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM06001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:31.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719893347234</udiDi>
    <basicUdiDi>B-04719893347234</basicUdiDi>
    <tradeName>WiZARD 520</tradeName>
    <deviceName>Full Face Mask</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM12002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:29.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883070395</udiDi>
    <basicUdiDi>B-04719883070395</basicUdiDi>
    <tradeName>Respitronics Elite Nebulization Therapy System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pu Yuan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000026655</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Respitronics Elite</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:58:42.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875347443</udiDi>
    <basicUdiDi>B-04719875347443</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName>Respiratory Humidifier</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-VH3000-220-UK</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:42.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875347375</udiDi>
    <basicUdiDi>B-04719875347375</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName>Respiratory Humidifier</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-VH3000-220-EU</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:41.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875347368</udiDi>
    <basicUdiDi>B-04719875347368</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName>Respiratory Humidifier</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-VH3000-110-US</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:40.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875347283</udiDi>
    <basicUdiDi>B-04719875347283</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName>Respiratory Humidifier</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-VH1500-220-US</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:39.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875347269</udiDi>
    <basicUdiDi>B-04719875347269</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName>Respiratory Humidifier</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-VH1500-220-UK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:35.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875347214</udiDi>
    <basicUdiDi>B-04719875347214</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName>Respiratory Humidifier</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-VH1500-220-B0088</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:35.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875347207</udiDi>
    <basicUdiDi>B-04719875347207</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName>Respiratory Humidifier</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-VH1500-220-EU</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:33.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875347191</udiDi>
    <basicUdiDi>B-04719875347191</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName>Respiratory Humidifier</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-VH1500-110-US</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:32.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875347122</udiDi>
    <basicUdiDi>B-04719875347122</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName>Respiratory Humidifier</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-VH1500-220-B0306</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:28.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875346507</udiDi>
    <basicUdiDi>B-04719875346507</basicUdiDi>
    <tradeName>Reusable Humidifier Chamber</tradeName>
    <deviceName>Reusable Humidifier Chamber</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060280</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-314005-EN</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:27.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875346477</udiDi>
    <basicUdiDi>B-04719875346477</basicUdiDi>
    <tradeName>Reusable Humidifier Chamber</tradeName>
    <deviceName>Reusable Humidifier Chamber</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060280</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-314004-EN</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:26.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875346453</udiDi>
    <basicUdiDi>B-04719875346453</basicUdiDi>
    <tradeName>Reusable Humidifier Chamber</tradeName>
    <deviceName>Reusable Humidifier Chamber</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060280</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-314003-EN</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:26.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875346446</udiDi>
    <basicUdiDi>B-04719875346446</basicUdiDi>
    <tradeName>Reusable Humidifier Chamber</tradeName>
    <deviceName>Reusable Humidifier Chamber</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060280</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-314002-EN</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:22.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875344053</udiDi>
    <basicUdiDi>B-04719875344053</basicUdiDi>
    <tradeName>Humidifier Chamber</tradeName>
    <deviceName>Humidifier Chamber</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060280</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-314003-P-B0088</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:21.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875344039</udiDi>
    <basicUdiDi>B-04719875344039</basicUdiDi>
    <tradeName>Humidifier Chamber</tradeName>
    <deviceName>Humidifier Chamber</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060280</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-314003-P-EN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:20.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875343995</udiDi>
    <basicUdiDi>B-04719875343995</basicUdiDi>
    <tradeName>Humidifier Chamber</tradeName>
    <deviceName>Humidifier Chamber</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060280</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-314001-B-EN1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:19.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719875343971</udiDi>
    <basicUdiDi>B-04719875343971</basicUdiDi>
    <tradeName>Humidifier Chamber</tradeName>
    <deviceName>Humidifier Chamber</deviceName>
    <manufacturerName>VADI Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000022930</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060280</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-314001-0-EN</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:14.904Z</lastUpdated>
  </row>
</eudamedExport>