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<eudamedExport entity="devices">
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    <basicUdiDi>69449327FR01A15K8</basicUdiDi>
    <tradeName>Welllead Multi-vent Mask</tradeName>
    <deviceName>Multi-vent Mask</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A07011Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:24.742Z</lastUpdated>
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    <udiDi>06944932767560</udiDi>
    <basicUdiDi>69449327FR01A16KA</basicUdiDi>
    <tradeName>Welllead  Multi-vent Mask</tradeName>
    <deviceName>Multi-vent Mask</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A07011F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:23.587Z</lastUpdated>
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  <row>
    <udiDi>06944932757400</udiDi>
    <basicUdiDi>69449327FR01A05K5</basicUdiDi>
    <tradeName>Welllead Multi-vent Mask</tradeName>
    <deviceName>Multi-vent Mask</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A05011Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:12.806Z</lastUpdated>
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    <udiDi>06923980102745</udiDi>
    <basicUdiDi>69239801ND2MGPW</basicUdiDi>
    <tradeName>AM-3 Adj-Venturi Mask, Adult w/Tube</tradeName>
    <deviceName>Disposable Oxygen therapy</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0079</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:05.019Z</lastUpdated>
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    <udiDi>04710810082573</udiDi>
    <basicUdiDi>471081008NND57C</basicUdiDi>
    <tradeName>AM-4 Trachea Mask, Adult</tradeName>
    <deviceName>Trachea Mask</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:59.823Z</lastUpdated>
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    <udiDi>04710810081538</udiDi>
    <basicUdiDi>471081008NND47A</basicUdiDi>
    <tradeName>AM-1 Venturi Mask, Adult</tradeName>
    <deviceName>Venturi Mask</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0098</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:10.066Z</lastUpdated>
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  <row>
    <udiDi>00890404552300</udiDi>
    <basicUdiDi>89040455230SJ</basicUdiDi>
    <tradeName>00890404552300</tradeName>
    <deviceName>Venturi Mask</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:20.024Z</lastUpdated>
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  <row>
    <udiDi>00890404552324</udiDi>
    <basicUdiDi>89040455230SJ</basicUdiDi>
    <tradeName>00890404552324</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5232</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:55:27.600Z</lastUpdated>
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  <row>
    <udiDi>06940626003044</udiDi>
    <basicUdiDi>B-06940626003044</basicUdiDi>
    <tradeName>06940626003044</tradeName>
    <deviceName>Venturi Mask</deviceName>
    <manufacturerName>Hangzhou Superds Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030075</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0304</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:17:47.916Z</lastUpdated>
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  <row>
    <udiDi>06940626003037</udiDi>
    <basicUdiDi>B-06940626003037</basicUdiDi>
    <tradeName>06940626003037</tradeName>
    <deviceName>Venturi Mask</deviceName>
    <manufacturerName>Hangzhou Superds Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030075</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0303</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:17:46.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>06940626003020</udiDi>
    <basicUdiDi>B-06940626003020</basicUdiDi>
    <tradeName>06940626003020</tradeName>
    <deviceName>Venturi Mask</deviceName>
    <manufacturerName>Hangzhou Superds Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030075</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0302</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:17:45.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VM-98120AB</udiDi>
    <basicUdiDi>B-VM-98120AB</basicUdiDi>
    <tradeName>D-VM-98120AB</tradeName>
    <deviceName>Adjustable Venturi Mask, 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>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VM-98120</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:37.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VM-98110A8</udiDi>
    <basicUdiDi>B-VM-98110A8</basicUdiDi>
    <tradeName>D-VM-98110A8</tradeName>
    <deviceName>Adjustable Venturi Mask, 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>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VM-98110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:37.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VM-98022AA</udiDi>
    <basicUdiDi>B-VM-98022AA</basicUdiDi>
    <tradeName>Venturi Mask, 6 diluters, child</tradeName>
    <deviceName>Venturi Mask, 6 diluters(24%~50%), 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>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VM-98022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:36.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VM-98020A6</udiDi>
    <basicUdiDi>B-VM-98020A6</basicUdiDi>
    <tradeName>Venturi Mask,7 diluters, child</tradeName>
    <deviceName>Venturi Mask,7 diluters(24%~60%), 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>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VM-98020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:35.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VM-98012A7</udiDi>
    <basicUdiDi>B-VM-98012A7</basicUdiDi>
    <tradeName>Venturi Mask, 6 diluters, adult</tradeName>
    <deviceName>Venturi Mask, 6 diluters(24%~50%), 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>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VM-98012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:31.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VM-98010A3</udiDi>
    <basicUdiDi>B-VM-98010A3</basicUdiDi>
    <tradeName>Venturi Mask,7 diluters, adult</tradeName>
    <deviceName>Venturi Mask,7 diluters(24%~60%), 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>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VM-98010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:30.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908014490683</udiDi>
    <basicUdiDi>B-08908014490683</basicUdiDi>
    <tradeName>08908014490683</tradeName>
    <deviceName>Nasal cannula</deviceName>
    <manufacturerName>Medivac Surgical Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000051901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19220002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:29:47.801Z</lastUpdated>
  </row>
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    <udiDi>08908014490676</udiDi>
    <basicUdiDi>B-08908014490676</basicUdiDi>
    <tradeName>08908014490676</tradeName>
    <deviceName>Nasal cannula</deviceName>
    <manufacturerName>Medivac Surgical Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000051901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19220001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:29:47.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932757417</udiDi>
    <basicUdiDi>69449327FR01A05K5</basicUdiDi>
    <tradeName>Welllead Multi-vent Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A05021Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:58.940Z</lastUpdated>
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</eudamedExport>