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<eudamedExport entity="devices">
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    <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>
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  <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>
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  <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>
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    <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>
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  <row>
    <udiDi>00606959412286</udiDi>
    <basicUdiDi>B-00606959412286</basicUdiDi>
    <tradeName>DreamStation Humidifier, Rental</tradeName>
    <deviceName>DreamStation Humidifier, Rental</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RINXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:21:45.813Z</lastUpdated>
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  <row>
    <udiDi>00606959410855</udiDi>
    <basicUdiDi>B-00606959410855</basicUdiDi>
    <tradeName>DreamStation Humidifier, GB, Rental</tradeName>
    <deviceName>DreamStation Humidifier, GB, Rental</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGBXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:21:40.207Z</lastUpdated>
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  <row>
    <udiDi>00606959410831</udiDi>
    <basicUdiDi>B-00606959410831</basicUdiDi>
    <tradeName>DreamStation REMstar Humidifier GER, Rental</tradeName>
    <deviceName>DreamStation REMstar Humidifier GER, Rental</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RDEXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:21:35.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959061040</udiDi>
    <basicUdiDi>B-00606959061040</basicUdiDi>
    <tradeName>DreamStation Humidifier, INTL</tradeName>
    <deviceName>DreamStation Humidifier, INTL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:47.325Z</lastUpdated>
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  <row>
    <udiDi>00606959058545</udiDi>
    <basicUdiDi>B-00606959058545</basicUdiDi>
    <tradeName>A40 Pro/EFL, SysOne Htd Tube Hum, Italy</tradeName>
    <deviceName>A40 Pro/EFL, SysOne Htd Tube Hum, Italy</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITX3T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:25.720Z</lastUpdated>
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  <row>
    <udiDi>00606959058538</udiDi>
    <basicUdiDi>B-00606959058538</basicUdiDi>
    <tradeName>A40 Pro/EFL, SysOne Htd Tube Hum, Benelu</tradeName>
    <deviceName>A40 Pro/EFL, SysOne Htd Tube Hum, Benelu</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLX3T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:21.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959058514</udiDi>
    <basicUdiDi>B-00606959058514</basicUdiDi>
    <tradeName>A40 Pro/EFL, SysOne Htd Tube Hum, France</tradeName>
    <deviceName>A40 Pro/EFL, SysOne Htd Tube Hum, France</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRX3T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:20.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959058507</udiDi>
    <basicUdiDi>B-00606959058507</basicUdiDi>
    <tradeName>A40 Pro/EFL, SysOne Htd Tube Hum, Iberia</tradeName>
    <deviceName>A40 Pro/EFL, SysOne Htd Tube Hum, Iberia</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESX3T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:19.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959058491</udiDi>
    <basicUdiDi>B-00606959058491</basicUdiDi>
    <tradeName>A40 Pro/EFL, Sys One Heated Tube Hum, UK</tradeName>
    <deviceName>A40 Pro/EFL, Sys One Heated Tube Hum, UK</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBX3T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:15.304Z</lastUpdated>
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  <row>
    <udiDi>00606959058484</udiDi>
    <basicUdiDi>B-00606959058484</basicUdiDi>
    <tradeName>A40 Pro/EFL,SysOne Htd Tube Hum, Germany</tradeName>
    <deviceName>A40 Pro/EFL,SysOne Htd Tube Hum, Germany</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEX3T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:14.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959058095</udiDi>
    <basicUdiDi>B-00606959058095</basicUdiDi>
    <tradeName>DreamStation Humidifier, Ukraine</tradeName>
    <deviceName>DreamStation Humidifier, Ukraine</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UAXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:13.714Z</lastUpdated>
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  <row>
    <udiDi>00606959057951</udiDi>
    <basicUdiDi>B-00606959057951</basicUdiDi>
    <tradeName>A40 Pro/EFL, Sys One Heated Hum, Italy</tradeName>
    <deviceName>A40 Pro/EFL, Sys One Heated Hum, Italy</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITX3H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:12.910Z</lastUpdated>
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  <row>
    <udiDi>00606959057944</udiDi>
    <basicUdiDi>B-00606959057944</basicUdiDi>
    <tradeName>A40 Pro/EFL, Sys One Heated Hum, Benelux</tradeName>
    <deviceName>A40 Pro/EFL, Sys One Heated Hum, Benelux</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLX3H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:19:57.643Z</lastUpdated>
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    <udiDi>00606959057937</udiDi>
    <basicUdiDi>B-00606959057937</basicUdiDi>
    <tradeName>A40 Pro/EFL, Sys One Heated Hum, Nordics</tradeName>
    <deviceName>A40 Pro/EFL, Sys One Heated Hum, Nordics</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDX3H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:19:56.858Z</lastUpdated>
  </row>
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    <udiDi>00606959057913</udiDi>
    <basicUdiDi>B-00606959057913</basicUdiDi>
    <tradeName>A40 Pro/EFL, Sys One Heated Hum, Iberia</tradeName>
    <deviceName>A40 Pro/EFL, Sys One Heated Hum, Iberia</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESX3H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:19:52.046Z</lastUpdated>
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  <row>
    <udiDi>00606959057906</udiDi>
    <basicUdiDi>B-00606959057906</basicUdiDi>
    <tradeName>A40 Pro/EFL, Sys One Heated Hum, UK</tradeName>
    <deviceName>A40 Pro/EFL, Sys One Heated Hum, UK</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBX3H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:19:51.246Z</lastUpdated>
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</eudamedExport>