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<eudamedExport entity="devices">
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    <udiDi>00606959424920</udiDi>
    <basicUdiDi>B-00606959424920</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AE AAM w/Humidifier, AU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AE AAM w/Humidifier, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AUX1131H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:23:41.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424913</udiDi>
    <basicUdiDi>B-00606959424913</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 AE, AU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 AE, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AUX1131S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:23:41.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959423619</udiDi>
    <basicUdiDi>B-00606959423619</basicUdiDi>
    <tradeName>BiPAP A40 Pro Titration Rental Program DE</tradeName>
    <deviceName>BiPAP A40 Pro Titration Rental Program 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RDEX3100S13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:22:34.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959423206</udiDi>
    <basicUdiDi>B-00606959423206</basicUdiDi>
    <tradeName>BiPAP A40 Pro Titration Rental Program IT</tradeName>
    <deviceName>BiPAP A40 Pro Titration Rental Program IT</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RITX3100S21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:22:33.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959422865</udiDi>
    <basicUdiDi>B-00606959422865</basicUdiDi>
    <tradeName>BiPAP A40 Pro Titration Rental Program ES</tradeName>
    <deviceName>BiPAP A40 Pro Titration Rental Program ES</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESX3100S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:22:29.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959422728</udiDi>
    <basicUdiDi>B-00606959422728</basicUdiDi>
    <tradeName>BiPAP A40 Pro Titration Rental Program FR</tradeName>
    <deviceName>BiPAP A40 Pro Titration Rental Program FR</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFRX3100S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:22:27.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959422698</udiDi>
    <basicUdiDi>B-00606959422698</basicUdiDi>
    <tradeName>BiPAP A40 Pro Titration Rental Program EE</tradeName>
    <deviceName>BiPAP A40 Pro Titration Rental Program EE</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REEX3100S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:22:23.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959422544</udiDi>
    <basicUdiDi>B-00606959422544</basicUdiDi>
    <tradeName>BiPAP A40 Pro Titration Rental Program IN</tradeName>
    <deviceName>BiPAP A40 Pro Titration Rental Program IN</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RINX3100S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:22:16.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959418981</udiDi>
    <basicUdiDi>B-00606959418981</basicUdiDi>
    <tradeName>Rental, DreamStation ST30, GB</tradeName>
    <deviceName>Rental, DreamStation ST30, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGBX1030S20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:22:14.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959418905</udiDi>
    <basicUdiDi>B-00606959418905</basicUdiDi>
    <tradeName>Filtered Exhalation Port (FEP) FPH 150PK</tradeName>
    <deviceName>Filtered Exhalation Port (FEP) FPH 150PK</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1140613</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:21:59.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959418721</udiDi>
    <basicUdiDi>B-00606959418721</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30, GB Rental</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGBX1130S20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:21:58.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959416185</udiDi>
    <basicUdiDi>B-00606959416185</basicUdiDi>
    <tradeName>Filtered Exhalation Port (FEP) S/A, 150PK</tradeName>
    <deviceName>Filtered Exhalation Port (FEP) S/A, 150PK</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1134664</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:21:54.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959065758</udiDi>
    <basicUdiDi>B-00606959065758</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T25, No Bluetooth, IN</tradeName>
    <deviceName>DreamStation BiPAP S/T25, No Bluetooth, IN</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1025H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:21:27.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062061</udiDi>
    <basicUdiDi>B-00606959062061</basicUdiDi>
    <tradeName>BeLife 40 Pro</tradeName>
    <deviceName>BeLife 40 Pro</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPX3100S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:51.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059467</udiDi>
    <basicUdiDi>B-00606959059467</basicUdiDi>
    <tradeName>BiPAP A40 Pro BR</tradeName>
    <deviceName>BiPAP A40 Pro BR</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRX3100S18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:46.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059443</udiDi>
    <basicUdiDi>B-00606959059443</basicUdiDi>
    <tradeName>BiPAP A40 Pro AR</tradeName>
    <deviceName>BiPAP A40 Pro AR</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARX3100S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:45.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059382</udiDi>
    <basicUdiDi>B-00606959059382</basicUdiDi>
    <tradeName>BiPAP A40 Pro, ES w/Heated Tube Humid</tradeName>
    <deviceName>BiPAP A40 Pro, ES w/Heated Tube Humid</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESX3100T19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:40.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059375</udiDi>
    <basicUdiDi>B-00606959059375</basicUdiDi>
    <tradeName>BiPAP A40 Pro, ES w/Heated Humidifier</tradeName>
    <deviceName>BiPAP A40 Pro, ES w/Heated Humidifier</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESX3100H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:39.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059368</udiDi>
    <basicUdiDi>B-00606959059368</basicUdiDi>
    <tradeName>BiPAP A40 Pro, ES</tradeName>
    <deviceName>BiPAP A40 Pro, ES</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESX3100S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:38.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059238</udiDi>
    <basicUdiDi>B-00606959059238</basicUdiDi>
    <tradeName>BiPAP A40 Pro, IA w/Heated Humidifier</tradeName>
    <deviceName>BiPAP A40 Pro, IA w/Heated Humidifier</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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IAX3100H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:20:32.913Z</lastUpdated>
  </row>
</eudamedExport>