<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06923980103124</udiDi>
    <basicUdiDi>69239801ND2BINZ</basicUdiDi>
    <tradeName>EVA Anes Ckt, Child, 1.2m w/Bag-1L</tradeName>
    <deviceName>Disposable Anesthesia 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></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0242</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:14.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980103094</udiDi>
    <basicUdiDi>69239801NR2RAT3</basicUdiDi>
    <tradeName>Manifold, 3 Way, PSF</tradeName>
    <deviceName>Reusable Valve and 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></emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:13.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102875</udiDi>
    <basicUdiDi>69239801NR2QASY</basicUdiDi>
    <tradeName>Silicone Hose, 17T, 60cm w/Cuff 22Fx2</tradeName>
    <deviceName>Reusable Tubing and Hose</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></emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS CONNECTION PIPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT0019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:13.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102806</udiDi>
    <basicUdiDi>69239801ND2KAPC</basicUdiDi>
    <tradeName>AM-6 Trachea Mask, Adult</tradeName>
    <deviceName>Disposable Mask</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></emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:12.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102790</udiDi>
    <basicUdiDi>69239801ND2MEPS</basicUdiDi>
    <tradeName>OM-4 Trachea Mask, Adult w/Tubing</tradeName>
    <deviceName>Disposable Oxygen therapy</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></emdnCode>
    <emdnDescription>TRACHEOSTOMY O2 SUPPLIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:11.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102776</udiDi>
    <basicUdiDi>69239801ND2MFPU</basicUdiDi>
    <tradeName>OM-2 HiO2 Mask, Adult w/Tubing, PVC Bag</tradeName>
    <deviceName>Disposable Oxygen therapy</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></emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0093</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:10.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102752</udiDi>
    <basicUdiDi>69239801ND2MAPJ</basicUdiDi>
    <tradeName>OM-2 Mask, Child w/Tubing</tradeName>
    <deviceName>Disposable Oxygen therapy</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></emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:09.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102745</udiDi>
    <basicUdiDi>69239801ND2MGPW</basicUdiDi>
    <tradeName>AM-3 Adj-Venturi Mask, Adult w/Tube</tradeName>
    <deviceName>Disposable Oxygen therapy</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></emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0079</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:09.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102516</udiDi>
    <basicUdiDi>69239801ND2LAPF</basicUdiDi>
    <tradeName>LVN Nebulizer, PP</tradeName>
    <deviceName>Disposable Nebulizer</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></emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0032</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:08.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102509</udiDi>
    <basicUdiDi>69239801ND2EANS</basicUdiDi>
    <tradeName>BH-1 Bubble Humidifier, 2PSI</tradeName>
    <deviceName>Disposable Bubble humidifier</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></emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:07.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102486</udiDi>
    <basicUdiDi>69239801ND2FANV</basicUdiDi>
    <tradeName>Auto Chamber, Adult</tradeName>
    <deviceName>Disposable Humidification Chamber</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></emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:06.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102462</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Filter, 22F/15M, 22M/15F</tradeName>
    <deviceName>Disposable Filter</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></emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:05.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102448</udiDi>
    <basicUdiDi>69239801FD2AAKN</basicUdiDi>
    <tradeName>LVN Nebulizer Kit</tradeName>
    <deviceName>Disposable Aerosol therapy</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></emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0099</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:05.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102387</udiDi>
    <basicUdiDi>69239801ND2GANY</basicUdiDi>
    <tradeName>Connector, 22F, 22F, K Resin</tradeName>
    <deviceName>Disposable Connector</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></emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:04.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102370</udiDi>
    <basicUdiDi>69239801NR2GAS2</basicUdiDi>
    <tradeName>CPAP Exhale Vent, 22M, 22M</tradeName>
    <deviceName>Reusable Connector</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></emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:03.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102257</udiDi>
    <basicUdiDi>69239801ND2QAPW</basicUdiDi>
    <tradeName>EVA Catheter mount, 22/15mm, 15M, 15cm</tradeName>
    <deviceName>Disposable Tubing and hose</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></emdnCode>
    <emdnDescription>MOBILE CATHETER MOUNTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0194</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:02.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102233</udiDi>
    <basicUdiDi>69239801ND2CANL</basicUdiDi>
    <tradeName>Breathing Bag, 1L, Latex</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></emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0104</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:01.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102226</udiDi>
    <basicUdiDi>69239801ND2DBNR</basicUdiDi>
    <tradeName>nCannula Kit, #0&amp;1</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></emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0062</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:01.028Z</lastUpdated>
  </row>
  <row>
    <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></emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:00.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980102202</udiDi>
    <basicUdiDi>69239801NR1EARP</basicUdiDi>
    <tradeName>Headgear for CPAP Mask, L, Silicone</tradeName>
    <deviceName>Reusable Headgear</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:28:59.419Z</lastUpdated>
  </row>
</eudamedExport>