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<eudamedExport entity="devices">
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    <udiDi>00606959427235</udiDi>
    <basicUdiDi>B-00606959427235</basicUdiDi>
    <tradeName>DreamStation CPAP Pro with Humidifier, GB</tradeName>
    <deviceName>DreamStation CPAP Pro with Humidifier, GB</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBX400H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:12.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425965</udiDi>
    <basicUdiDi>B-00606959425965</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV w/Humidifier, TR</tradeName>
    <deviceName>DreamStation BiPAP autoSV w/Humidifier, TR</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRX900H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:28.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425866</udiDi>
    <basicUdiDi>B-00606959425866</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV , No Bluetooth, EU</tradeName>
    <deviceName>DreamStation BiPAP autoSV , No Bluetooth, EU</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUX900S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:26.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425842</udiDi>
    <basicUdiDi>B-00606959425842</basicUdiDi>
    <tradeName>DreamStation BiPAP AutoSV, EU</tradeName>
    <deviceName>DreamStation BiPAP AutoSV, EU</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUX900S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:24.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425798</udiDi>
    <basicUdiDi>B-00606959425798</basicUdiDi>
    <tradeName>DreamStation, BiPAP AutoSV with Humidifier, DE</tradeName>
    <deviceName>DreamStation, BiPAP AutoSV with Humidifier, DE</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEX900H13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:22.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425774</udiDi>
    <basicUdiDi>B-00606959425774</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV w/Humidifier, BL</tradeName>
    <deviceName>DreamStation BiPAP autoSV w/Humidifier, BL</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLX900H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:21.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424852</udiDi>
    <basicUdiDi>B-00606959424852</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, AU</tradeName>
    <deviceName>DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, AU</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AUX900T15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:11.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424807</udiDi>
    <basicUdiDi>B-00606959424807</basicUdiDi>
    <tradeName>DreamStation CPAP Pro, INTL</tradeName>
    <deviceName>DreamStation CPAP Pro, 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX400S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:10.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424777</udiDi>
    <basicUdiDi>B-00606959424777</basicUdiDi>
    <tradeName>DreamStation BiPAP Pro with Humidifier, INTL</tradeName>
    <deviceName>DreamStation BiPAP Pro with 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX600H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:09.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424722</udiDi>
    <basicUdiDi>B-00606959424722</basicUdiDi>
    <tradeName>DreamStation CPAP Pro w/Humid w/H Tube, INTL</tradeName>
    <deviceName>DreamStation CPAP Pro w/Humid w/H Tube, 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX400T15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:07.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424715</udiDi>
    <basicUdiDi>B-00606959424715</basicUdiDi>
    <tradeName>DreamStation CPAP Pro with Humidifier, INTL</tradeName>
    <deviceName>DreamStation CPAP Pro with 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX400H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:05.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424692</udiDi>
    <basicUdiDi>B-00606959424692</basicUdiDi>
    <tradeName>DreamStation CPAP with Humidifier, INTL</tradeName>
    <deviceName>DreamStation CPAP with 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX200H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:03.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424685</udiDi>
    <basicUdiDi>B-00606959424685</basicUdiDi>
    <tradeName>DreamStation CPAP, INTL</tradeName>
    <deviceName>DreamStation CPAP, 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX200S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:02.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959413863</udiDi>
    <basicUdiDi>B-00606959413863</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV w/ Humid, DE Rental</tradeName>
    <deviceName>DreamStation BiPAP autoSV w/ Humid, DE 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RDEX900H13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:58:50.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959413832</udiDi>
    <basicUdiDi>B-00606959413832</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV, GB Rental</tradeName>
    <deviceName>DreamStation BiPAP autoSV, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGBX900S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:58:49.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959412927</udiDi>
    <basicUdiDi>B-00606959412927</basicUdiDi>
    <tradeName>DreamStation Travel Kit, 65W P/S, AU</tradeName>
    <deviceName>DreamStation Travel Kit, 65W P/S, AU</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AU1120135</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:58:45.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959063587</udiDi>
    <basicUdiDi>B-00606959063587</basicUdiDi>
    <tradeName>DS2Adv Auto CPAP w/Humid BT only, EU</tradeName>
    <deviceName>DS2Adv Auto CPAP w/Humid BT only, EU</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUX520H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:58:44.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959410848</udiDi>
    <basicUdiDi>B-00606959410848</basicUdiDi>
    <tradeName>DreamStation Auto CPAP, GB Rental</tradeName>
    <deviceName>DreamStation Auto CPAP, 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGBX500S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:58:42.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971914891081</udiDi>
    <basicUdiDi>697191489VEN8SU</basicUdiDi>
    <tradeName>Positive Airway Pressure Device</tradeName>
    <deviceName>Positive Airway Pressure Device</deviceName>
    <manufacturerName>Guangzhou Hypnus Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035782</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>CA820M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:22:02.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971914890930</udiDi>
    <basicUdiDi>697191489VEN3SJ</basicUdiDi>
    <tradeName>Positive Airway Pressure Device</tradeName>
    <deviceName>Positive Airway Pressure Device</deviceName>
    <manufacturerName>Guangzhou Hypnus Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035782</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>CA720W</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:22:01.746Z</lastUpdated>
  </row>
</eudamedExport>