<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00619498279630</udiDi>
    <basicUdiDi>619498EC11264</basicUdiDi>
    <tradeName>HOMECARE STAND (WITHOUT INTERFACE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27963</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:25.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498279562</udiDi>
    <basicUdiDi>619498EC11264</basicUdiDi>
    <tradeName>ASTRAL SERIES TOP PLATE KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27956</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:54.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498279593</udiDi>
    <basicUdiDi>619498EC11264</basicUdiDi>
    <tradeName>AIR 10 SERIES TOP PLATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27959</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:54.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498279616</udiDi>
    <basicUdiDi>619498EC11264</basicUdiDi>
    <tradeName>HOMECARE STAND ASTRAL PLATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27961</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:33.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498279647</udiDi>
    <basicUdiDi>619498EC11264</basicUdiDi>
    <tradeName>AIR 10 ‐ LUMIS SERIES TOP PLATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27964</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:33.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>00619498392315</udiDi>
    <basicUdiDi>619498EC1806M</basicUdiDi>
    <tradeName>AIR 11 DC-DC CONVERTER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39231</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:27.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850030671004</udiDi>
    <basicUdiDi>0850040313ML6S</basicUdiDi>
    <tradeName>CPAP Mask Liners</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RespiraSource, OPC</manufacturerName>
    <manufacturerSrn>PH-MF-000013799</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B092JQT9W4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:22.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850038100711</udiDi>
    <basicUdiDi>0850040313ML6S</basicUdiDi>
    <tradeName>CPAP Mask Liners</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RespiraSource, OPC</manufacturerName>
    <manufacturerSrn>PH-MF-000013799</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B07X4YGJQJ</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:22.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097057306</udiDi>
    <basicUdiDi>6948097014MZMZJR</basicUdiDi>
    <tradeName>06948097057306</tradeName>
    <deviceName>Anesthesia Masks for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:20.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097057313</udiDi>
    <basicUdiDi>6948097014MZMZJR</basicUdiDi>
    <tradeName>06948097057313</tradeName>
    <deviceName>Anesthesia Masks for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:20.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097057320</udiDi>
    <basicUdiDi>6948097014MZMZJR</basicUdiDi>
    <tradeName>06948097057320</tradeName>
    <deviceName>Anesthesia Masks for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:20.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097057337</udiDi>
    <basicUdiDi>6948097014MZMZJR</basicUdiDi>
    <tradeName>06948097057337</tradeName>
    <deviceName>Anesthesia Masks for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:20.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097057344</udiDi>
    <basicUdiDi>6948097014MZMZJR</basicUdiDi>
    <tradeName>06948097057344</tradeName>
    <deviceName>Anesthesia Masks for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:20.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097057351</udiDi>
    <basicUdiDi>6948097014MZMZJR</basicUdiDi>
    <tradeName>06948097057351</tradeName>
    <deviceName>Anesthesia Masks for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:20.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097057368</udiDi>
    <basicUdiDi>6948097014MZMZJR</basicUdiDi>
    <tradeName>06948097057368</tradeName>
    <deviceName>Anesthesia Masks for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:20.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B882900150%</udiDi>
    <basicUdiDi>++B88290015KD</basicUdiDi>
    <tradeName>LungFit® PH Verification Kit</tradeName>
    <deviceName>LungFit® PH Verification Kit</deviceName>
    <manufacturerName>Beyond Air, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047279</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019002</emdnCode>
    <emdnDescription>NITRIC OXIDE DISPENSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90015</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:14:32.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B882900140+</udiDi>
    <basicUdiDi>++B88290014KB</basicUdiDi>
    <tradeName>LungFit® PH NDM Assembly</tradeName>
    <deviceName>LungFit® PH NDM Assembly</deviceName>
    <manufacturerName>Beyond Air, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047279</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019002</emdnCode>
    <emdnDescription>NITRIC OXIDE DISPENSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90014</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:14:31.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B8829000801</udiDi>
    <basicUdiDi>++B88290008KG</basicUdiDi>
    <tradeName>LungFit® PH NO2 Filter</tradeName>
    <deviceName>LungFit® PH NO2 Filter</deviceName>
    <manufacturerName>Beyond Air, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047279</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019002</emdnCode>
    <emdnDescription>NITRIC OXIDE DISPENSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:14:28.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B882900050+</udiDi>
    <basicUdiDi>++B88290005KA</basicUdiDi>
    <tradeName>LungFit® PH Bagging Kit</tradeName>
    <deviceName>LungFit® PH Bagging Kit</deviceName>
    <manufacturerName>Beyond Air, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047279</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203019002</emdnCode>
    <emdnDescription>NITRIC OXIDE DISPENSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:14:26.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959026078</udiDi>
    <basicUdiDi>B-40606959026078</basicUdiDi>
    <tradeName>Disposable Adult Passive Circuit no H20 Trap 20 pk</tradeName>
    <deviceName>Disposable Adult Passive Circuit no H20 Trap 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>1073236</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:33.585Z</lastUpdated>
  </row>
</eudamedExport>