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<eudamedExport entity="devices">
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    <udiDi>04710810104473</udiDi>
    <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>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>06923980104701</udiDi>
    <basicUdiDi>69239801ND2CBNN</basicUdiDi>
    <tradeName>Breathing Bag, 2L, Latex Free</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>AB0019</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105302</udiDi>
    <basicUdiDi>69239801ND2CBNN</basicUdiDi>
    <tradeName>Breathing Bag, 3L, Latex Free</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>AB0271</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105319</udiDi>
    <basicUdiDi>69239801ND2CCNQ</basicUdiDi>
    <tradeName>MR-100 Reservoir Bag, 600ml</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>AR0020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105326</udiDi>
    <basicUdiDi>69239801ND2CBNN</basicUdiDi>
    <tradeName>Breathing Bag, 0.5L, Latex Free</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>AB0017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105333</udiDi>
    <basicUdiDi>69239801ND2CBNN</basicUdiDi>
    <tradeName>Breathing Bag, 1L, Latex Free</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>AB0018</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105340</udiDi>
    <basicUdiDi>69239801ND2CBNN</basicUdiDi>
    <tradeName>Breathing Bag, 0.5L, Latex Free</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>AB0119</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105357</udiDi>
    <basicUdiDi>69239801ND2CBNN</basicUdiDi>
    <tradeName>Breathing Bag, 1L, Latex Free</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>AB0120</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105364</udiDi>
    <basicUdiDi>69239801ND2CBNN</basicUdiDi>
    <tradeName>Breathing Bag, 2L, Latex Free</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>AB0121</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980106880</udiDi>
    <basicUdiDi>69239801ND1FANQ</basicUdiDi>
    <tradeName>TC-1 Hose Clip, 15F w/3 clips</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 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>AB0102</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:01.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980106941</udiDi>
    <basicUdiDi>69239801ND1GANT</basicUdiDi>
    <tradeName>nBonnet, #2/S, Yellow</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 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>AN0006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:01.686Z</lastUpdated>
  </row>
</eudamedExport>