<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055788778530</udiDi>
    <basicUdiDi>B-05055788778530</basicUdiDi>
    <tradeName>05055788778530</tradeName>
    <deviceName>HME Booster Heater</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>358 932 400</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:51:50.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055788778523</udiDi>
    <basicUdiDi>B-05055788778523</basicUdiDi>
    <tradeName>05055788778523</tradeName>
    <deviceName>HME Booster Heater</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>358 931 400</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:51:49.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055788778516</udiDi>
    <basicUdiDi>B-05055788778516</basicUdiDi>
    <tradeName>05055788778516</tradeName>
    <deviceName>HME Booster Heater</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>358 930 400</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:51:48.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055788776222</udiDi>
    <basicUdiDi>B-05055788776222</basicUdiDi>
    <tradeName>05055788776222</tradeName>
    <deviceName>HME Booster Heater</deviceName>
    <manufacturerName>Flexicare Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000034163</manufacturerSrn>
    <authorisedRepresentativeName>Flexicare EU Ops Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000048902</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>358 933 400</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:51:47.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733991297</udiDi>
    <basicUdiDi>697273399RHNeoHiFi5i7SN</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEYER Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014712</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060202</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000145</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T06:10:53.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733991457</udiDi>
    <basicUdiDi>697273399RHNeoHiFi5i7SN</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEYER Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014712</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060202</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000145</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T06:10:53.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733992003</udiDi>
    <basicUdiDi>697273399RHNeoHiFi5i7SN</basicUdiDi>
    <tradeName>Respiratory Humidifier</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEYER Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014712</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060202</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000200</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-27T06:10:53.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670118</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670118</tradeName>
    <deviceName>697061467A00014G</deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:21.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670125</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670125</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670132</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670132</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670149</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670149</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670163</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670163</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670170</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670170</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670187</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670187</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670194</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670194</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670200</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670217</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670217</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670224</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670224</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:07.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670231</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670231</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:06.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614670248</udiDi>
    <basicUdiDi>697061467A00014G</basicUdiDi>
    <tradeName>06970614670248</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Weihai Shengjie Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032283</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:06.952Z</lastUpdated>
  </row>
</eudamedExport>