<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10620974003608</udiDi>
    <basicUdiDi>6209741423241517149A</basicUdiDi>
    <tradeName>Oxy2Pro Plus</tradeName>
    <deviceName>Oxy2Pro</deviceName>
    <manufacturerName>Southmedic Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000005669</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRP-2110-MDT</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:01.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160914</udiDi>
    <basicUdiDi>697551916OMNSTQ</basicUdiDi>
    <tradeName>16975519160914</tradeName>
    <deviceName>Disposable Oxygen Mask</deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Adult-S-02(non sterile)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:46:18.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945099392718</udiDi>
    <basicUdiDi>69450993SOM001VF</basicUdiDi>
    <tradeName>Medium Concentration Oxygen Mask</tradeName>
    <deviceName>Medium Concentration Oxygen Mask</deviceName>
    <manufacturerName>Ningbo Shengyurui Medical Appliances Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026643</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0101-S5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:02.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932766884</udiDi>
    <basicUdiDi>69449327FR01A06K7</basicUdiDi>
    <tradeName>Welllead  Multi-vent Mask</tradeName>
    <deviceName>Multi-vent Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A05011F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:23.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881167966</udiDi>
    <basicUdiDi>69449327FR01A01JV</basicUdiDi>
    <tradeName>Wellleaad Oxygen Mask</tradeName>
    <deviceName>Oxygen Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A01011F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:59:05.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881166938</udiDi>
    <basicUdiDi>69449327FR01A00JT</basicUdiDi>
    <tradeName>Wellleaad Oxygen Mask</tradeName>
    <deviceName>Oxygen Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A02018F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:59:05.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816660443</udiDi>
    <basicUdiDi>69449327FR01A04K3</basicUdiDi>
    <tradeName>Welllead Non-Rebreath Mask</tradeName>
    <deviceName>Non-Rebreath Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A04013F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:10.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931515061078</udiDi>
    <basicUdiDi>69315150MW105J9</basicUdiDi>
    <tradeName>06931515061078</tradeName>
    <deviceName>Oxygen Mask</deviceName>
    <manufacturerName>HOSPITAL&amp;HOMECARE IMP. &amp; EXP. CO.,LTD NANJING</manufacturerName>
    <manufacturerSrn>CN-MF-000038483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW10501001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:49:51.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105937</udiDi>
    <basicUdiDi>69239801ND2MDPQ</basicUdiDi>
    <tradeName>M3 Oxygen Masks, L</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:01.099Z</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:11.416Z</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:05.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310902755</udiDi>
    <basicUdiDi>69233109PA05LY</basicUdiDi>
    <tradeName>Oxygen Mask</tradeName>
    <deviceName>Oxygen Mask</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:18:41.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004251993</udiDi>
    <basicUdiDi>622300425OFM2007TS</basicUdiDi>
    <tradeName>ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Paediatric Standard)</tradeName>
    <deviceName>ULTRAMED OXYGEN FACE MASK</deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2007-02</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:30:49.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004251603</udiDi>
    <basicUdiDi>622300425OFM2004TL</basicUdiDi>
    <tradeName>ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Adult Standard)</tradeName>
    <deviceName>ULTRAMED OXYGEN FACE MASK</deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2004-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:30:47.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770662305</udiDi>
    <basicUdiDi>4716770CP06600DR</basicUdiDi>
    <tradeName>Cardiopulmonary Resuscitation Pocket Resuscitator Set</tradeName>
    <deviceName>CPR Pocket Resuscitator Set</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-66230</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:33:40.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810100673</udiDi>
    <basicUdiDi>471081008NND67E</basicUdiDi>
    <tradeName>NHF Prong Kit, #1</tradeName>
    <deviceName>NHF Prong 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0113</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:41.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810089053</udiDi>
    <basicUdiDi>471081008NND87J</basicUdiDi>
    <tradeName>Gas Sampling Line, 300cm, 4F, 4M</tradeName>
    <deviceName>Gas Sampling Line</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0060</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:36.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083969</udiDi>
    <basicUdiDi>471081008NND97L</basicUdiDi>
    <tradeName>Flow Meter Adaptor, White</tradeName>
    <deviceName>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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0076</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:20.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082092</udiDi>
    <basicUdiDi>471081008NND276</basicUdiDi>
    <tradeName>OM-2 Mask, Child</tradeName>
    <deviceName>Oxygen 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:30.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082054</udiDi>
    <basicUdiDi>471081008NND174</basicUdiDi>
    <tradeName>C22 Star Lumen Tubing, 1000cm</tradeName>
    <deviceName>Oxygen Tubing</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:24.396Z</lastUpdated>
  </row>
</eudamedExport>