<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CA-63607PG</udiDi>
    <basicUdiDi>B-CA-63607PG</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Standard Elbow and corrugate tube, size S</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63607</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:01.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-63606PE</udiDi>
    <basicUdiDi>B-CA-63606PE</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Standard Elbow, size XL</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63606</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:00.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-63609PL</udiDi>
    <basicUdiDi>B-CA-63609PL</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Anti-Asphyxia Elbow and corrugate tube, size S</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63609</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:58.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-63608PJ</udiDi>
    <basicUdiDi>B-CA-63608PJ</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Anti-Asphyxia Elbow, size XL</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63608</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:58.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-63605PC</udiDi>
    <basicUdiDi>B-CA-63605PC</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Anti-Asphyxia Elbow and corrugate tube, size XS</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63605</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:41.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-63604PA</udiDi>
    <basicUdiDi>B-CA-63604PA</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Anti-Asphyxia Elbow, size L</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63604</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:40.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-63603P8</udiDi>
    <basicUdiDi>B-CA-63603P8</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Standard Elbow and corrugate tube, size XS</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63603</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:39.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-63602P6</udiDi>
    <basicUdiDi>B-CA-63602P6</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Standard Elbow, size L</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63602</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:38.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-63601P4</udiDi>
    <basicUdiDi>B-CA-63601P4</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Anti-Asphyxia Elbow, size M</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63601</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:34.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA-63600P2</udiDi>
    <basicUdiDi>B-CA-63600P2</basicUdiDi>
    <tradeName>FitMax CPAP Total face mask</tradeName>
    <deviceName>FitMax CPAP Total face mask with Standard Elbow, size M</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63600</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:33.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>74710961931378</udiDi>
    <basicUdiDi>B-74710961931378</basicUdiDi>
    <tradeName>Silicone Mask</tradeName>
    <deviceName>Silicone Mask</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1611-9002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:01:57.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>74710961931361</udiDi>
    <basicUdiDi>B-74710961931361</basicUdiDi>
    <tradeName>Silicone Mask</tradeName>
    <deviceName>Silicone Mask</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1611-9001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:01:53.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>44710961931520</udiDi>
    <basicUdiDi>B-44710961931520</basicUdiDi>
    <tradeName>Air-Cush Mask</tradeName>
    <deviceName>Air-Cush Mask</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1691-9005</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:00.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>44710961931513</udiDi>
    <basicUdiDi>B-44710961931513</basicUdiDi>
    <tradeName>Air-Cush Mask</tradeName>
    <deviceName>Air-Cush Mask</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1691-9004</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:00.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>44710961931407</udiDi>
    <basicUdiDi>B-44710961931407</basicUdiDi>
    <tradeName>Silicone Mask</tradeName>
    <deviceName>Silicone Mask</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1611-9005</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:59.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>44710961931353</udiDi>
    <basicUdiDi>B-44710961931353</basicUdiDi>
    <tradeName>Silicone Mask</tradeName>
    <deviceName>1611-9000</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1611-9000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:55.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>44710961931377</udiDi>
    <basicUdiDi>B-44710961931377</basicUdiDi>
    <tradeName>Silicone Mask</tradeName>
    <deviceName>Silicone Mask</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1611-9002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:53.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>44710961931360</udiDi>
    <basicUdiDi>B-44710961931360</basicUdiDi>
    <tradeName>Silicone Mask</tradeName>
    <deviceName>Silicone Mask</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1611-9001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:43:52.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959000740</udiDi>
    <basicUdiDi>B-40606959000740</basicUdiDi>
    <tradeName>CONTOUR DELUXE SU W/HEADGEAR, M/L, INT – 10 PK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1016696</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:02:11.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959000733</udiDi>
    <basicUdiDi>B-40606959000733</basicUdiDi>
    <tradeName>CONTOUR DELUXE SU W/HEADGEAR, S, INT – 10 PACK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1016698</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:02:11.059Z</lastUpdated>
  </row>
</eudamedExport>