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<eudamedExport entity="devices">
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    <udiDi>06923980102219</udiDi>
    <basicUdiDi>69239801ND2DANP</basicUdiDi>
    <tradeName>Bubble PAP Valve</tradeName>
    <deviceName>Disposable Bubble CPAP system</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>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:46.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102127</udiDi>
    <basicUdiDi>69239801ND2SJQN</basicUdiDi>
    <tradeName>Gas Sampling Line, 300cm, 4M</tradeName>
    <deviceName>Disposable Ventilation Circuit</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>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0005</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:42.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980101014</udiDi>
    <basicUdiDi>69239801ND2RDQ7</basicUdiDi>
    <tradeName>Diverter Cap w/Valve, 30F</tradeName>
    <deviceName>Disposable Valve &amp; Manifold</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>R028001</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:31.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980100147</udiDi>
    <basicUdiDi>69239801ND2CCNQ</basicUdiDi>
    <tradeName>MR-100 Reservoir Bag, 600ml</tradeName>
    <deviceName>Disposable Breathing bag</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>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR0019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:20:28.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310900379</udiDi>
    <basicUdiDi>69233109PA27MA</basicUdiDi>
    <tradeName>Breathing Circuit</tradeName>
    <deviceName>Breathing Circuit</deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020199</emdnCode>
    <emdnDescription>BREATHING CIRCUITS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA27A11</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:17:51.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166510503</udiDi>
    <basicUdiDi>69221665RTT001R4</basicUdiDi>
    <tradeName>Heated breathing tube</tradeName>
    <deviceName>Heated breathing tube</deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YRT-T01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:12:36.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003563</udiDi>
    <basicUdiDi>54040130000000000000169</basicUdiDi>
    <tradeName>WM 29067 prismaHYBERNITE</tradeName>
    <deviceName>Active non implantable respiratory devices.</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPE19018WT0019GI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:58:19.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013000234</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 12 ins+Inc</tradeName>
    <deviceName>Hybernite RT</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPN12020BT1FQWBB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:58:17.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013000982</udiDi>
    <basicUdiDi>54040130000000000000169</basicUdiDi>
    <tradeName>S.Box HEATED TUBE</tradeName>
    <deviceName>Active non implantable respiratory devices.</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPE15018KT0030GI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:49:51.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013000227</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 12 ex</tradeName>
    <deviceName>Hybernite RT</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPN12016WT0FQWBB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:49:46.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013000807</udiDi>
    <basicUdiDi>54040130000000000000169</basicUdiDi>
    <tradeName>Hybernite HBT</tradeName>
    <deviceName>Active non implantable respiratory devices.</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HRN19018WT0ECWGC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:44:42.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013000210</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 12 ins</tradeName>
    <deviceName>Hybernite RT</deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPN12016BT1FTWBB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:44:27.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391530290654</udiDi>
    <basicUdiDi>539153029026005FN</basicUdiDi>
    <tradeName>Sedaconda ACD Starter Kit</tradeName>
    <deviceName>Sedaconda ACD Starter Kit</deviceName>
    <manufacturerName>Sedana Medical Limited</manufacturerName>
    <manufacturerSrn>IE-PR-000001737</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020399</emdnCode>
    <emdnDescription>ANESTHESIA AND RESUSCITATION CONNECTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2026030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:52:53.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060120950567</udiDi>
    <basicUdiDi>506012095Accessories264</basicUdiDi>
    <tradeName>Spiroguard Adaptor</tradeName>
    <deviceName>Anaesthesia and Resuscitation Connectors</deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020302</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2802/17BAEB001/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:28:01.591Z</lastUpdated>
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  <row>
    <udiDi>05060120950024</udiDi>
    <basicUdiDi>506012095Accessories162</basicUdiDi>
    <tradeName>Attachment</tradeName>
    <deviceName>Catheter Mounts</deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020299</emdnCode>
    <emdnDescription>MOUNT CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A620/60/61BAUA020/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:27:51.175Z</lastUpdated>
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  <row>
    <udiDi>04719873290017</udiDi>
    <basicUdiDi>47198732930VR</basicUdiDi>
    <tradeName>04719873290017</tradeName>
    <deviceName>Heated-wire circuit</deviceName>
    <manufacturerName>DA CHUNG MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000037960</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3495</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:45:12.870Z</lastUpdated>
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  <row>
    <udiDi>04719873433490</udiDi>
    <basicUdiDi>471096971TCF17II010163</basicUdiDi>
    <tradeName>Free Trachea Closed Suction Set</tradeName>
    <deviceName>Closed Suction System</deviceName>
    <manufacturerName>Pacific Hospital Supply Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007247</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020202</emdnCode>
    <emdnDescription>MOBILE CATHETER MOUNTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T20030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:37:53.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719873290000</udiDi>
    <basicUdiDi>47198732930VR</basicUdiDi>
    <tradeName>04719873290000</tradeName>
    <deviceName>Heated-wire circuit</deviceName>
    <manufacturerName>DA CHUNG MEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000037960</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R020107</emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3490</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:37:32.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810107566</udiDi>
    <basicUdiDi>471081008NNH67S</basicUdiDi>
    <tradeName>NRV, Straight, 22F, 22/15, 30M, 6M</tradeName>
    <deviceName>NRV&amp;Valve</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>R02010199</emdnCode>
    <emdnDescription>STANDARD BREATHING CIRCUITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0088</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:06.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810117626</udiDi>
    <basicUdiDi>471081008NNO287</basicUdiDi>
    <tradeName>Endo Mask, M w/Harness</tradeName>
    <deviceName>Endo 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>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW0065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:24.204Z</lastUpdated>
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</eudamedExport>