<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975164321015</udiDi>
    <basicUdiDi>697516432VentilatorS5</basicUdiDi>
    <tradeName>HM-B25</tradeName>
    <deviceName>Positive Airway Pressure Ventilator</deviceName>
    <manufacturerName>Shenzhen Hingmed Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004838</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:18:07.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070910204</udiDi>
    <basicUdiDi>697507091ST3M</basicUdiDi>
    <tradeName>bi-rich</tradeName>
    <deviceName>Sleep apnoea breathing therapy equipment</deviceName>
    <manufacturerName>ShenZhen Bi-rich Medical Devices Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023061</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR-20A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:04:15.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973855830532</udiDi>
    <basicUdiDi>697385583BPAP01RD</basicUdiDi>
    <tradeName>TOPSONMED, SS130</tradeName>
    <deviceName>Continuous Positive Airway Pressure Devices</deviceName>
    <manufacturerName>Hebei Topson Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024553</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS130</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:05:13.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973855830495</udiDi>
    <basicUdiDi>697385583CPAP01RS</basicUdiDi>
    <tradeName>TOPSONMED, SS100</tradeName>
    <deviceName>Continuous Positive Airway Pressure Devices</deviceName>
    <manufacturerName>Hebei Topson Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024553</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS100</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:05:09.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972860691688</udiDi>
    <basicUdiDi>697286069CPAPQU</basicUdiDi>
    <tradeName>BPAP device</tradeName>
    <deviceName>CONTINUOUS POSITIVE AIRWAY PRESSURE UNITS</deviceName>
    <manufacturerName>Xiaoniu Health Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014716</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000313</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:18:25.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166513405</udiDi>
    <basicUdiDi>69221665YHC005LC</basicUdiDi>
    <tradeName>Positive Airway Pressure Units</tradeName>
    <deviceName>Positive Airway Pressure Units</deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C502002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:23:56.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166513191</udiDi>
    <basicUdiDi>69221665YHB003KZ</basicUdiDi>
    <tradeName>Positive Airway Pressure Units</tradeName>
    <deviceName>Positive Airway Pressure Units</deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C453002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:23:55.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498391462</udiDi>
    <basicUdiDi>619498EC1997A</basicUdiDi>
    <tradeName>AIRCURVE 11 ASV PACEWAVE WE</tradeName>
    <deviceName>AirCurve 11 ASV PaceWave</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39146</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:01:14.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498391448</udiDi>
    <basicUdiDi>619498EC19878</basicUdiDi>
    <tradeName>AIRCURVE 11 VAUTO WE</tradeName>
    <deviceName>AirCurve 11 S , AirCurve 11 ST , AirCurve 11 VAuto</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39144</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:01:13.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498391400</udiDi>
    <basicUdiDi>619498EC19776</basicUdiDi>
    <tradeName>AirSense 11 AutoSet WE</tradeName>
    <deviceName>AirSense 11 AutoSet , AirSense 11 Elite</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39140</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:01:10.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498372751</udiDi>
    <basicUdiDi>619498EC1516E</basicUdiDi>
    <tradeName>AirCurve 10 CS PaceWave FR</tradeName>
    <deviceName>AirCurve 10 CS PaceWave</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37275</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:01:02.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498372386</udiDi>
    <basicUdiDi>619498EC1506C</basicUdiDi>
    <tradeName>AirCurve 10 VAuto FR</tradeName>
    <deviceName>AirCurve 10 S, AirCurve 10 ST, AirCurve 10 VAuto</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37238</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:01:01.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498372348</udiDi>
    <basicUdiDi>619498EC1496T</basicUdiDi>
    <tradeName>AirSense 10 Elite FR</tradeName>
    <deviceName>AirSense 10 AutoSet , AirSense 10 Elite , AirSense 10 AutoSet For Her , AirSense 10 AutoSet No CAM (C2C)</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37234</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:01:00.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498282838</udiDi>
    <basicUdiDi>619498EC1776Y</basicUdiDi>
    <tradeName>AIRCURVE 10 CS-A PACEWAVE GER CO</tradeName>
    <deviceName>AirCurve 10 CS-A Pacewave</deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28283</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:00:57.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760330371085</udiDi>
    <basicUdiDi>376033037ADAPTATION1DD</basicUdiDi>
    <tradeName>SENTRY MD98000120</tradeName>
    <deviceName>SENTRY 1200 ST</deviceName>
    <manufacturerName>MEDIDEV - SENTECH FRANCE</manufacturerName>
    <manufacturerSrn>FR-MF-000008021</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD98000120</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:26:02.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400868</udiDi>
    <basicUdiDi>3700659416409D</basicUdiDi>
    <tradeName>S.Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-116412</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:28:56.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700659400004</udiDi>
    <basicUdiDi>37006594170096</basicUdiDi>
    <tradeName>Néa Info</tradeName>
    <deviceName>Néa</deviceName>
    <manufacturerName>SEFAM</manufacturerName>
    <manufacturerSrn>FR-MF-000009061</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-117011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:28:40.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166500054</udiDi>
    <basicUdiDi>69221665YHC001L4</basicUdiDi>
    <tradeName>Positive Airway Pressure Units</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C102001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:10:43.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166500061</udiDi>
    <basicUdiDi>69221665YHC001L4</basicUdiDi>
    <tradeName>Positive Airway Pressure Units</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C101001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:10:43.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166510060</udiDi>
    <basicUdiDi>69221665YHB001KV</basicUdiDi>
    <tradeName>Positive Airway Pressure Units</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C153001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:10:42.977Z</lastUpdated>
  </row>
</eudamedExport>