<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SM-8623183</udiDi>
    <basicUdiDi>B-SM-8623183</basicUdiDi>
    <tradeName>D-SM-8623183</tradeName>
    <deviceName>Silicone Cushion Mask, Polycarbonate, Size 3</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86231</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:37.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8622282</udiDi>
    <basicUdiDi>B-SM-8622282</basicUdiDi>
    <tradeName>D-SM-8622282</tradeName>
    <deviceName>Silicone Cushion Mask, Polysulfone, Size 2</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86222</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:33.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-862217Y</udiDi>
    <basicUdiDi>B-SM-862217Y</basicUdiDi>
    <tradeName>D-SM-862217Y</tradeName>
    <deviceName>Silicone Cushion Mask, Polycarbonate, Size 2</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86221</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:32.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8615286</udiDi>
    <basicUdiDi>B-SM-8615286</basicUdiDi>
    <tradeName>Silicone Mask, Size 5, Adult Large</tradeName>
    <deviceName>Silicone Mask, Size 5, Adult Large</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86152</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:31.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8615184</udiDi>
    <basicUdiDi>B-SM-8615184</basicUdiDi>
    <tradeName>D-SM-8615184</tradeName>
    <deviceName>Silicone Mask, Size 5, Adult Large</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86151</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:30.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8614283</udiDi>
    <basicUdiDi>B-SM-8614283</basicUdiDi>
    <tradeName>Silicone Mask, Size 4, Adult</tradeName>
    <deviceName>Silicone Mask, Size 4, Adult</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86142</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:26.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-861417Z</udiDi>
    <basicUdiDi>B-SM-861417Z</basicUdiDi>
    <tradeName>D-SM-861417Z</tradeName>
    <deviceName>Silicone Mask, Size 4, Adult</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86141</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:25.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-861327Y</udiDi>
    <basicUdiDi>B-SM-861327Y</basicUdiDi>
    <tradeName>Silicone Mask, Size 3, Child Large</tradeName>
    <deviceName>Silicone Mask, Size 3, Child Large</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86132</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:25.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-861317W</udiDi>
    <basicUdiDi>B-SM-861317W</basicUdiDi>
    <tradeName>D-SM-861317W</tradeName>
    <deviceName>Silicone Mask, Size 3, Child Large</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86131</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:24.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF000025583HFL0006KD</udiDi>
    <basicUdiDi>B-ITMF000025583HFL0006KD</basicUdiDi>
    <tradeName>KHFL/CM</tradeName>
    <deviceName>Accessories for airway clearance</deviceName>
    <manufacturerName>Medical Products Research</manufacturerName>
    <manufacturerSrn>IT-MF-000025583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHFL/CM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:04:18.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF000025583HFL0005KB</udiDi>
    <basicUdiDi>B-ITMF000025583HFL0005KB</basicUdiDi>
    <tradeName>KHFL/CM</tradeName>
    <deviceName>Accessories for high flow therapy</deviceName>
    <manufacturerName>Medical Products Research</manufacturerName>
    <manufacturerSrn>IT-MF-000025583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHFL/CM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:04:17.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF000025583HFL0004K9</udiDi>
    <basicUdiDi>B-ITMF000025583HFL0004K9</basicUdiDi>
    <tradeName>KHFL/CA</tradeName>
    <deviceName>Accessories for high flow oxygen therapy</deviceName>
    <manufacturerName>Medical Products Research</manufacturerName>
    <manufacturerSrn>IT-MF-000025583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHFL/CA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:04:16.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF000025583HFL0003K7</udiDi>
    <basicUdiDi>B-ITMF000025583HFL0003K7</basicUdiDi>
    <tradeName>KHFL/A</tradeName>
    <deviceName>Accessories for airway clearance</deviceName>
    <manufacturerName>Medical Products Research</manufacturerName>
    <manufacturerSrn>IT-MF-000025583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHFL/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:04:14.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF000025583HFL0001K3</udiDi>
    <basicUdiDi>B-ITMF000025583HFL0001K3</basicUdiDi>
    <tradeName>KHFL/HFA</tradeName>
    <deviceName>Accessories for high flow oxigen therapy</deviceName>
    <manufacturerName>Medical Products Research</manufacturerName>
    <manufacturerSrn>IT-MF-000025583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KHFL/HFA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:04:12.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF000025583FAA0001C7</udiDi>
    <basicUdiDi>B-ITMF000025583FAA0001C7</basicUdiDi>
    <tradeName>KFAA</tradeName>
    <deviceName>Accessories for Airway clearance</deviceName>
    <manufacturerName>Medical Products Research</manufacturerName>
    <manufacturerSrn>IT-MF-000025583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFAA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:04:10.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITMF000025583FA000016P</udiDi>
    <basicUdiDi>B-ITMF000025583FA000016P</basicUdiDi>
    <tradeName>KFA/F</tradeName>
    <deviceName>Accessories for airway clearance</deviceName>
    <manufacturerName>Medical Products Research</manufacturerName>
    <manufacturerSrn>IT-MF-000025583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFA/F</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:04:06.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HE-74510UM</udiDi>
    <basicUdiDi>B-HE-74510UM</basicUdiDi>
    <tradeName>D-HE-74510UM</tradeName>
    <deviceName>Disposable Head Strap</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE-74510</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:32.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HE-74300U8</udiDi>
    <basicUdiDi>B-HE-74300U8</basicUdiDi>
    <tradeName>D-HE-74300U8</tradeName>
    <deviceName>Silicone Head Strap, Adult</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE-74300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:31.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HE-74200U3</udiDi>
    <basicUdiDi>B-HE-74200U3</basicUdiDi>
    <tradeName>D-HE-74200U3</tradeName>
    <deviceName>Silicone Head Strap, Child</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE-74200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:26.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CT-17343YD</udiDi>
    <basicUdiDi>B-CT-17343YD</basicUdiDi>
    <tradeName>Breathing Circuit, 1.8m, Parallel Elbow, Latex Free Bag 1L, Child</tradeName>
    <deviceName>Breathing Circuit, Ø 15mm, 1.8m, Parallel Elbow, Latex Free Bag 1L, Child</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT-17343</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:32:02.038Z</lastUpdated>
  </row>
</eudamedExport>