<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SM-865538U</udiDi>
    <basicUdiDi>B-SM-865538U</basicUdiDi>
    <tradeName>D-SM-865538U</tradeName>
    <deviceName>Silicone Mask, Size 5</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-86553</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:33:21.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-865238K</udiDi>
    <basicUdiDi>B-SM-865238K</basicUdiDi>
    <tradeName>D-SM-865238K</tradeName>
    <deviceName>Silicone Mask, 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-86523</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:33:17.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-865138G</udiDi>
    <basicUdiDi>B-SM-865138G</basicUdiDi>
    <tradeName>D-SM-865138G</tradeName>
    <deviceName>Silicone Mask, Size 1</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-86513</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:33:17.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-865438R</udiDi>
    <basicUdiDi>B-SM-865438R</basicUdiDi>
    <tradeName>D-SM-865438R</tradeName>
    <deviceName>Silicone Mask, Size 4</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-86543</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:33:16.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-865338N</udiDi>
    <basicUdiDi>B-SM-865338N</basicUdiDi>
    <tradeName>D-SM-865338N</tradeName>
    <deviceName>Silicone Mask, 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-86533</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:33:15.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-865038D</udiDi>
    <basicUdiDi>B-SM-865038D</basicUdiDi>
    <tradeName>D-SM-865038D</tradeName>
    <deviceName>Silicone Mask, Size 0</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-86503</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:58.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-864338H</udiDi>
    <basicUdiDi>B-SM-864338H</basicUdiDi>
    <tradeName>D-SM-864338H</tradeName>
    <deviceName>Rendell Baker Silicone Mask with Exhalation Valve, 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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86433</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:57.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-864238E</udiDi>
    <basicUdiDi>B-SM-864238E</basicUdiDi>
    <tradeName>D-SM-864238E</tradeName>
    <deviceName>Rendell Baker Silicone Mask with Exhalation Valve, 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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86423</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:57.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-864138B</udiDi>
    <basicUdiDi>B-SM-864138B</basicUdiDi>
    <tradeName>D-SM-864138B</tradeName>
    <deviceName>Rendell Baker Silicone Mask with Exhalation Valve, 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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-86413</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:56.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-863338C</udiDi>
    <basicUdiDi>B-SM-863338C</basicUdiDi>
    <tradeName>D-SM-863338C</tradeName>
    <deviceName>Rendell Baker Silicone Mask, 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-86333</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:52.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8632389</udiDi>
    <basicUdiDi>B-SM-8632389</basicUdiDi>
    <tradeName>D-SM-8632389</tradeName>
    <deviceName>Rendell Baker Silicone Mask, 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-86323</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:51.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8631386</udiDi>
    <basicUdiDi>B-SM-8631386</basicUdiDi>
    <tradeName>D-SM-8631386</tradeName>
    <deviceName>Rendell Baker Silicone Mask, Size 1</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-86313</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:50.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8630383</udiDi>
    <basicUdiDi>B-SM-8630383</basicUdiDi>
    <tradeName>D-SM-8630383</tradeName>
    <deviceName>Rendell Baker Silicone Mask, Size 0</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-86303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:49.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-862628E</udiDi>
    <basicUdiDi>B-SM-862628E</basicUdiDi>
    <tradeName>D-SM-862628E</tradeName>
    <deviceName>Silicone Cushion Mask, Polysulfone, Size 6</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-86262</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:45.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-862618C</udiDi>
    <basicUdiDi>B-SM-862618C</basicUdiDi>
    <tradeName>D-SM-862618C</tradeName>
    <deviceName>Silicone Cushion Mask, Polycarbonate, Size 6</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-86261</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:45.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-862528B</udiDi>
    <basicUdiDi>B-SM-862528B</basicUdiDi>
    <tradeName>D-SM-862528B</tradeName>
    <deviceName>Silicone Cushion Mask, Polysulfone, Size 5</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-86252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:44.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8625189</udiDi>
    <basicUdiDi>B-SM-8625189</basicUdiDi>
    <tradeName>D-SM-8625189</tradeName>
    <deviceName>Silicone Cushion Mask, Polycarbonate, Size 5</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-86251</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:43.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8624288</udiDi>
    <basicUdiDi>B-SM-8624288</basicUdiDi>
    <tradeName>D-SM-8624288</tradeName>
    <deviceName>Silicone Cushion Mask, Polysulfone, Size 4</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-86242</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:39.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8624186</udiDi>
    <basicUdiDi>B-SM-8624186</basicUdiDi>
    <tradeName>D-SM-8624186</tradeName>
    <deviceName>Silicone Cushion Mask, Polycarbonate, Size 4</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-86241</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:38.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SM-8623285</udiDi>
    <basicUdiDi>B-SM-8623285</basicUdiDi>
    <tradeName>D-SM-8623285</tradeName>
    <deviceName>Silicone Cushion Mask, Polysulfone, 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-86232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:32:37.849Z</lastUpdated>
  </row>
</eudamedExport>