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<eudamedExport entity="devices">
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    <udiDi>04710810115875</udiDi>
    <basicUdiDi>471081008RNP89J</basicUdiDi>
    <tradeName>CPAP Exhale Vent, 22M, 22M</tradeName>
    <deviceName>Reusable Other Connector</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>AC0019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:24.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810115622</udiDi>
    <basicUdiDi>471081008NNG17D</basicUdiDi>
    <tradeName>Adj PLS Valve, 2-10cmH2O, 22F</tradeName>
    <deviceName>Accessories</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>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0066</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:19.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810114809</udiDi>
    <basicUdiDi>471081008NNBW98</basicUdiDi>
    <tradeName>Guedel Airway 120mm, Purple</tradeName>
    <deviceName>Oropharyngeal airway</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>MDR 2017/745</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW0003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:18.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810105487</udiDi>
    <basicUdiDi>471081008NNHB8G</basicUdiDi>
    <tradeName>Silicone Single Limb Circuit, Adult</tradeName>
    <deviceName>Silicone Circuit</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>AB0337</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:06.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810104732</udiDi>
    <basicUdiDi>471081008RNH58L</basicUdiDi>
    <tradeName>Valve for Manifold, Silicone, Green</tradeName>
    <deviceName>Reusable Manifold</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>AV0015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:05.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810104459</udiDi>
    <basicUdiDi>471081008NNCN8R</basicUdiDi>
    <tradeName>nBonnet, #1/XS, Green</tradeName>
    <deviceName>nBonnet</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>MDR 2017/745</legislation>
    <emdnCode>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:04.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810103872</udiDi>
    <basicUdiDi>471081008NNGN95</basicUdiDi>
    <tradeName>nCannula Kit, #0 w/nBonnet</tradeName>
    <deviceName>nCannula Kit</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>R02010401</emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0075</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:26:03.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810104428</udiDi>
    <basicUdiDi>471081008NNRNA6</basicUdiDi>
    <tradeName>nAPV Circuit</tradeName>
    <deviceName>nAPV Circuit</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>AN0028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:59.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810103001</udiDi>
    <basicUdiDi>471081008NNH17G</basicUdiDi>
    <tradeName>EVA Circuit, adult</tradeName>
    <deviceName>EVA  Circuit</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>R02010102</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0235</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:58.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810089732</udiDi>
    <basicUdiDi>471081008NNQ28D</basicUdiDi>
    <tradeName>ESB Breathing Tube, 22F, 60cm</tradeName>
    <deviceName>Hytrel Hose</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>AT0065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:40.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810087943</udiDi>
    <basicUdiDi>471081008NNPC9A</basicUdiDi>
    <tradeName>Connector, 22/15mm, 15M, 6M</tradeName>
    <deviceName>S Connector</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>AC0188</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:35.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810086571</udiDi>
    <basicUdiDi>471081008RNH78Q</basicUdiDi>
    <tradeName>Silicone Catheter Mount, 30cm</tradeName>
    <deviceName>Reusable Catheter Mount</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>AT0039</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:35.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084577</udiDi>
    <basicUdiDi>471081008RNP69E</basicUdiDi>
    <tradeName>DS-L Connector w/Suction Port, 15F, 15M, PSF</tradeName>
    <deviceName>Reusable DS-L Connector</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>AC0117</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:32.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084515</udiDi>
    <basicUdiDi>471081008RNP59C</basicUdiDi>
    <tradeName>L Connector, 22F, 22/15mm, PSF</tradeName>
    <deviceName>Reusable L Connector</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>AC0021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:29.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084478</udiDi>
    <basicUdiDi>471081008RNH28E</basicUdiDi>
    <tradeName>Water Trap, 22M, Amber</tradeName>
    <deviceName>Reusable Water Trap</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>R02010102</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0113</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:27.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084317</udiDi>
    <basicUdiDi>471081008NNP48E</basicUdiDi>
    <tradeName>SY Connector, 22/15mm, 22M</tradeName>
    <deviceName>SY Connector</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>AC0029</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:27.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084225</udiDi>
    <basicUdiDi>471081008RNQ299</basicUdiDi>
    <tradeName>Hytrel Hose, 10F/10T, 60cm, Ivory</tradeName>
    <deviceName>Reusable Hytrel Hose</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>AT0007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:22.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083976</udiDi>
    <basicUdiDi>471081008NNH77U</basicUdiDi>
    <tradeName>Trachea Tee Set, w/Tubing</tradeName>
    <deviceName>Catheter Mount</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>AO0058</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:21.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083891</udiDi>
    <basicUdiDi>471081008RNI48M</basicUdiDi>
    <tradeName>Sil.Flex Catheter Mount,22/15mm,15M, PSF</tradeName>
    <deviceName>Reusable Catheter Mount</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>AB0147</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:19.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083686</udiDi>
    <basicUdiDi>471081008NNH47N</basicUdiDi>
    <tradeName>Adj. PEEP Valve, 5~20cmH2O, 22M</tradeName>
    <deviceName>Peep 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>AV0018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:16.629Z</lastUpdated>
  </row>
</eudamedExport>