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<eudamedExport entity="devices">
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    <basicUdiDi>471081008NNCN8R</basicUdiDi>
    <tradeName>nBonnet, #3/M, Red</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:57.185Z</lastUpdated>
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  <row>
    <udiDi>04710810104480</udiDi>
    <basicUdiDi>471081008NNCN8R</basicUdiDi>
    <tradeName>nBonnet, #4/L, Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:57.167Z</lastUpdated>
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    <udiDi>04710810104497</udiDi>
    <basicUdiDi>471081008NNCN8R</basicUdiDi>
    <tradeName>nBonnet, #5/XL, Black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:57.141Z</lastUpdated>
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    <udiDi>04710810115110</udiDi>
    <basicUdiDi>471081008NNTB9L</basicUdiDi>
    <tradeName>TC-4 Hose Clip, 22F w/2 clips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R028002</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0029</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:52.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810115127</udiDi>
    <basicUdiDi>471081008NNTB9L</basicUdiDi>
    <tradeName>TC-2 Hose Clip, 22F w/5 clips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R028002</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:52.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707480029679</udiDi>
    <basicUdiDi>570748030100803108N</basicUdiDi>
    <tradeName>Reusable PEEP 20 valve</tradeName>
    <deviceName>Ambu® Reusable PEEP Valve</deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R028001</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A000177000</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:35:38.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707480021758</udiDi>
    <basicUdiDi>570748030100803058V</basicUdiDi>
    <tradeName>Ambu® Disposable PEEP 20 valve</tradeName>
    <deviceName>Ambu® Disposable PEEP Valve</deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R028001</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>199102001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:35:10.897Z</lastUpdated>
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    <udiDi>05055788776925</udiDi>
    <basicUdiDi>5055788700056C13M2</basicUdiDi>
    <tradeName>05055788776925</tradeName>
    <deviceName>Breathing System Components and Accessories</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2105488-006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:47.605Z</lastUpdated>
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  <row>
    <udiDi>04055146800263</udiDi>
    <basicUdiDi>40551461001019DB</basicUdiDi>
    <tradeName>04055146800263</tradeName>
    <deviceName>Exhalation valve</deviceName>
    <manufacturerName>WILAmed GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007207</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R028001</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260622</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:24:15.573Z</lastUpdated>
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    <udiDi>04055146086537</udiDi>
    <basicUdiDi>40551461001146DK</basicUdiDi>
    <tradeName>04055146086537</tradeName>
    <deviceName>Cover Nordkap</deviceName>
    <manufacturerName>WILAmed GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007207</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2701581</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:24:07.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>04042301207104</udiDi>
    <basicUdiDi>4042301R0280AASA</basicUdiDi>
    <tradeName>pfm NeoBreathe CPAP Ventil</tradeName>
    <deviceName>NeoBreathe</deviceName>
    <manufacturerName>PFM medical mepro GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005190</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R028001</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEONB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:54:36.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675008361</udiDi>
    <basicUdiDi>040486751208044PK19T030A7</basicUdiDi>
    <tradeName>Kondensatabscheider EX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R028003</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS WATER TRAPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8409627</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:58:32.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881191398</udiDi>
    <basicUdiDi>69449327FA13C02D5</basicUdiDi>
    <tradeName>Gas Sampling Line</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>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A13C02027X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:07.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881191411</udiDi>
    <basicUdiDi>69449327FA13C09DK</basicUdiDi>
    <tradeName>Gas Sampling Line</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>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A13C020225</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:07.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980103131</udiDi>
    <basicUdiDi>69239801ND2CANL</basicUdiDi>
    <tradeName>Breathing Bag, 2L, Latex</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0105</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:05.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980103384</udiDi>
    <basicUdiDi>69239801ND2CANL</basicUdiDi>
    <tradeName>Breathing Bag, 0.5L, Latex</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0103</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:05.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980103391</udiDi>
    <basicUdiDi>69239801ND2CANL</basicUdiDi>
    <tradeName>Breathing Bag, 3L, Latex</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0106</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:05.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980103544</udiDi>
    <basicUdiDi>69239801ND2TAQ7</basicUdiDi>
    <tradeName>Water Trap, 15M</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>R028003</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS WATER TRAPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0324</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:05.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980104084</udiDi>
    <basicUdiDi>69239801NR2RAT3</basicUdiDi>
    <tradeName>Manifold, 2 Way, PSF</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>R028001</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0078</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980104497</udiDi>
    <basicUdiDi>69239801ND2TAQ7</basicUdiDi>
    <tradeName>Water Trap, 25ml, 15M, Blue</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>R028003</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS WATER TRAPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.627Z</lastUpdated>
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</eudamedExport>