<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>30606959402264</udiDi>
    <basicUdiDi>B-30606959402264</basicUdiDi>
    <tradeName>Flex Trach Adapter 15cm, 22M/15F-15 20 pk</tradeName>
    <deviceName>Flex Trach Adapter 15cm, 22M/15F-15 20 pk</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>1073903</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:27.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959054500</udiDi>
    <basicUdiDi>B-30606959054500</basicUdiDi>
    <tradeName>(10) Disposable Active Exhalation Valve</tradeName>
    <deviceName>(10) Disposable Active Exhalation Valve</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>1131661</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:24.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959051752</udiDi>
    <basicUdiDi>B-30606959051752</basicUdiDi>
    <tradeName>Circuit, Disposable, 15mm, Non-Heated, Passive</tradeName>
    <deviceName>Circuit, Disposable, 15mm, Non-Heated, Passive</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>1132339</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:23.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959049551</udiDi>
    <basicUdiDi>B-30606959049551</basicUdiDi>
    <tradeName>Circuit, Disposable, 22mm, Adult, Non-Heated Passive</tradeName>
    <deviceName>Circuit, Disposable, 22mm, Adult, Non-Heated Passive</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>1132340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:22.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959042347</udiDi>
    <basicUdiDi>B-30606959042347</basicUdiDi>
    <tradeName>BiPAP Disposable Circuit, Box/10</tradeName>
    <deviceName>BiPAP Disposable Circuit, Box/10</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>312107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:20.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959024220</udiDi>
    <basicUdiDi>B-30606959024220</basicUdiDi>
    <tradeName>Disposable Pediatric Circuit with H20 Trap</tradeName>
    <deviceName>Disposable Pediatric Circuit with H20 Trap</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>1073220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:18.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959002563</udiDi>
    <basicUdiDi>B-30606959002563</basicUdiDi>
    <tradeName>Pressure Valve, 5 Pack</tradeName>
    <deviceName>Pressure Valve, 5 Pack</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>302423</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:17.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682146425</udiDi>
    <basicUdiDi>8406821BUG00345HH</basicUdiDi>
    <tradeName>Carestation 750c A1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012-9755-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:19:29.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166515188</udiDi>
    <basicUdiDi>69221665YHB002KX</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>C302007</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-28T03:55:37.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733990573</udiDi>
    <basicUdiDi>697273399030105NV_NIVPL</basicUdiDi>
    <tradeName>Ventilator</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:27.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733990580</udiDi>
    <basicUdiDi>697273399030105NV_NIVPL</basicUdiDi>
    <tradeName>Ventilator</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:27.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733990665</udiDi>
    <basicUdiDi>697273399030105NV_NIVPL</basicUdiDi>
    <tradeName>Ventilator</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000234</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:27.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733990672</udiDi>
    <basicUdiDi>697273399030105NV_NIVPL</basicUdiDi>
    <tradeName>Ventilator</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000235</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:27.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733990696</udiDi>
    <basicUdiDi>697273399030105NV_NIVPL</basicUdiDi>
    <tradeName>Ventilator</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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000236</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:27.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733990733</udiDi>
    <basicUdiDi>697273399AC_MC340BT3</basicUdiDi>
    <tradeName>Medical air compressor</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>Z1203010580</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR HOSPITAL USE - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115000064</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:27.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733991594</udiDi>
    <basicUdiDi>697273399030101AGXB</basicUdiDi>
    <tradeName>Anaesthetic Workstation</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>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111035225</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:26.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733991600</udiDi>
    <basicUdiDi>697273399030101AGXB</basicUdiDi>
    <tradeName>Anaesthetic Workstation</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>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111035226</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:26.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733997022</udiDi>
    <basicUdiDi>697273399030101AGXB</basicUdiDi>
    <tradeName>Anaesthetic Workstation</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>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111034222</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:26.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733999811</udiDi>
    <basicUdiDi>697273399VP_VP500/3005P</basicUdiDi>
    <tradeName>Vaporizer</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>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121000981</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T20:18:26.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971914890947</udiDi>
    <basicUdiDi>697191489VEN3SJ</basicUdiDi>
    <tradeName>Positive Airway Pressure Device</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA720M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:28:15.795Z</lastUpdated>
  </row>
</eudamedExport>