<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04710810118616</udiDi>
    <basicUdiDi>471081008NND47A</basicUdiDi>
    <tradeName>LAV Venturi Mask Kit, child</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0162</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810118623</udiDi>
    <basicUdiDi>471081008NND47A</basicUdiDi>
    <tradeName>LAV Venturi Mask Kit, infant</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0163</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810118654</udiDi>
    <basicUdiDi>471081008NNH27J</basicUdiDi>
    <tradeName>Water Trap, 25ml, 15M, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810118692</udiDi>
    <basicUdiDi>471081008NNP58G</basicUdiDi>
    <tradeName>L Connector, 7.6M, Luer, PC</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0093</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119156</udiDi>
    <basicUdiDi>471081008NNH27J</basicUdiDi>
    <tradeName>Water Trap, 25ml, 10M, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0215</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119248</udiDi>
    <basicUdiDi>471081008RNH58L</basicUdiDi>
    <tradeName>Manifold, 2 Way, PSF</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0078</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119255</udiDi>
    <basicUdiDi>471081008RNH58L</basicUdiDi>
    <tradeName>Manifold w/7.6F, 2 Way, PSF</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0079</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119279</udiDi>
    <basicUdiDi>471081008NNH57Q</basicUdiDi>
    <tradeName>CV-3 Manifold</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119378</udiDi>
    <basicUdiDi>471081008NNED8B</basicUdiDi>
    <tradeName>RF Nebulizer Kit</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119385</udiDi>
    <basicUdiDi>471081008NNED8B</basicUdiDi>
    <tradeName>LF1 Nebulizer w/Valve T Kit, 22F</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0023</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119491</udiDi>
    <basicUdiDi>471081008NNH27J</basicUdiDi>
    <tradeName>CS Water Trap Kit, L Type, 10M</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0205</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119545</udiDi>
    <basicUdiDi>471081008NNH27J</basicUdiDi>
    <tradeName>CS Water Trap Kit, Y Type, 10M</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0209</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119552</udiDi>
    <basicUdiDi>471081008NNH27J</basicUdiDi>
    <tradeName>CS Water Trap Kit, Y Type, 15M</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0210</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119569</udiDi>
    <basicUdiDi>471081008NNH27J</basicUdiDi>
    <tradeName>CS Water Trap Kit, Y Type, 22M</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0211</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119576</udiDi>
    <basicUdiDi>471081008NNH27J</basicUdiDi>
    <tradeName>Tubing for CS Water Trap, Straight</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0216</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119583</udiDi>
    <basicUdiDi>471081008NNH27J</basicUdiDi>
    <tradeName>Tubing for CS Water Trap, Angled</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0217</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119637</udiDi>
    <basicUdiDi>471081008NNGN95</basicUdiDi>
    <tradeName>nCannula Kit, #0&amp;1</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119644</udiDi>
    <basicUdiDi>471081008NNGN95</basicUdiDi>
    <tradeName>nCannula Kit, #2&amp;3</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0063</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119651</udiDi>
    <basicUdiDi>471081008NNGN95</basicUdiDi>
    <tradeName>nCannula Kit, #4&amp;5</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0064</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810119668</udiDi>
    <basicUdiDi>471081008NNGN95</basicUdiDi>
    <tradeName>nCannula Kit, #6&amp;7</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:27.118Z</lastUpdated>
  </row>
</eudamedExport>