<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06926767206339</udiDi>
    <basicUdiDi>69267672016XN</basicUdiDi>
    <tradeName>06926767206339</tradeName>
    <deviceName>Breathing tubes intended for use with anaesthetic apparatus and ventilators</deviceName>
    <manufacturerName>Shandong Steve Medical Science &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034622</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R02010102</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Adult</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:40:33.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925457803612</udiDi>
    <basicUdiDi>6925457836000AT</basicUdiDi>
    <tradeName>Mesh Nebulizer</tradeName>
    <deviceName>Mesh Nebulizers</deviceName>
    <manufacturerName>Guangzhou AXD Electronic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037466</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AXD-361</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:26:25.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925457803018</udiDi>
    <basicUdiDi>69254578300009H</basicUdiDi>
    <tradeName>Medical Compressor Nebulizer</tradeName>
    <deviceName>Medical Compressor Nebulizers</deviceName>
    <manufacturerName>Guangzhou AXD Electronic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037466</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AXD-301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:26:21.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924993400118</udiDi>
    <basicUdiDi>692499340735365G</basicUdiDi>
    <tradeName>06924993400118</tradeName>
    <deviceName>Medical Face Mask</deviceName>
    <manufacturerName>Honz Pharmaceutical Co,.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024508</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030299</emdnCode>
    <emdnDescription>RESPIRATORY BALLOONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:25:09.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112744</udiDi>
    <basicUdiDi>69239801NR2KASE</basicUdiDi>
    <tradeName>NIV mask, small, including headgear</tradeName>
    <deviceName>Reusable 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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0074</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:32.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112263</udiDi>
    <basicUdiDi>69239801NR2CARN</basicUdiDi>
    <tradeName>Silicone Breathing Bag, 2L w/Loop End</tradeName>
    <deviceName>Reusable 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>AB0010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:31.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980111655</udiDi>
    <basicUdiDi>69239801FD2AEKW</basicUdiDi>
    <tradeName>Neb-1 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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:30.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980108860</udiDi>
    <basicUdiDi>69239801NR2QBT2</basicUdiDi>
    <tradeName>Hytrel Hose, 22F/19T, 150cm, Blue</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>R020301</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS CONNECTION PIPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT0023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:27.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980108334</udiDi>
    <basicUdiDi>69239801ND2MBPL</basicUdiDi>
    <tradeName>NHF Prong Kit, #4</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>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:13.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980106996</udiDi>
    <basicUdiDi>69239801ND1ECNR</basicUdiDi>
    <tradeName>Headgear for Nasal Mask, L</tradeName>
    <deviceName>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>R03010180</emdnCode>
    <emdnDescription>ARTIFICIAL VENTILATION MASKS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:13.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980108211</udiDi>
    <basicUdiDi>69239801NR2BARK</basicUdiDi>
    <tradeName>Start-up Kit, Adult, Reusable</tradeName>
    <deviceName>Reusable 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>R02010101</emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XVY0080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:13.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980106934</udiDi>
    <basicUdiDi>69239801ND1GANT</basicUdiDi>
    <tradeName>nBonnet, #1/XS, Green</tradeName>
    <deviceName>nBonnet</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>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:09.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980106866</udiDi>
    <basicUdiDi>69239801ND1FCNU</basicUdiDi>
    <tradeName>TC-4 Hose Clip, 22F w/2 clips</tradeName>
    <deviceName>Hose clip</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>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:03.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980106859</udiDi>
    <basicUdiDi>69239801ND1FANQ</basicUdiDi>
    <tradeName>TC-1 Hose Clip, 15F w/3 clips</tradeName>
    <deviceName>Hose clip</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>R028099</emdnCode>
    <emdnDescription>RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0008</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:02.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980106507</udiDi>
    <basicUdiDi>69239801ND2RCQ5</basicUdiDi>
    <tradeName>Tail-end control valve</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>AB0328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:01.905Z</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>06923980105456</udiDi>
    <basicUdiDi>69239801FD2ABKQ</basicUdiDi>
    <tradeName>Neb.Easy w/T-Connector, Tubing</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0048</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:56.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105432</udiDi>
    <basicUdiDi>69239801FD2AFKY</basicUdiDi>
    <tradeName>Neb.Easy Nebulizer w/Mouth Piece, Tube</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:55.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980104770</udiDi>
    <basicUdiDi>69239801ND2JAP9</basicUdiDi>
    <tradeName>HME w/Tube, 22F, 15F</tradeName>
    <deviceName>Disposable HME</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>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:55.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980104749</udiDi>
    <basicUdiDi>69239801ND2HAP3</basicUdiDi>
    <tradeName>CPAP Face Mask Set w/Hose, L</tradeName>
    <deviceName>Disposable CPAP 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0120</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:21:50.693Z</lastUpdated>
  </row>
</eudamedExport>