<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00814747024744</udiDi>
    <basicUdiDi>08147470219NA</basicUdiDi>
    <tradeName>Arie Full Face Vented Mask Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sleepnet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010620</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50851</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:48:49.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>03666256013316</udiDi>
    <basicUdiDi>3666256D0100A00VENU0804TJ</basicUdiDi>
    <tradeName>Masque hyperventilation adulte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Int'Air Médical</manufacturerName>
    <manufacturerSrn>FR-MF-000000328</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPP91</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:24:48.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>03666256011343</udiDi>
    <basicUdiDi>3666256D01000P0VENU080284</basicUdiDi>
    <tradeName>Ballon réservoir Capacité 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Int'Air Médical</manufacturerName>
    <manufacturerSrn>FR-MF-000000328</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020101</emdnCode>
    <emdnDescription>ANAESTHESIA BALLOONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAG1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:24:42.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989242</udiDi>
    <basicUdiDi>08908003989Hornpuff54</basicUdiDi>
    <tradeName>Horn puff</tradeName>
    <deviceName>Infant T-piece Resuscitator with Accessories</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:23:17.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908003989075</udiDi>
    <basicUdiDi>08908003989OperahplusTW</basicUdiDi>
    <tradeName>Operah plus</tradeName>
    <deviceName>Infant Radiant Warmer with T-piece Resuscitator, Phototherapy and Accessories</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020201</emdnCode>
    <emdnDescription>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5000 RP</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:23:10.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097016693</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097016693</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:57.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097016709</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097016709</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:57.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097062201</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097062201</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:19.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097062218</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097062218</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:19.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097062225</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097062225</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:19.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097062232</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097062232</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:19.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097062249</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097062249</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:19.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097062256</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097062256</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:19.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097062263</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097062263</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:19.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097062270</udiDi>
    <basicUdiDi>6948097009BYGK5</basicUdiDi>
    <tradeName>06948097062270</tradeName>
    <deviceName>Nasal Oxygen Cannulas 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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:19.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750005703</udiDi>
    <basicUdiDi>081713602691312BD</basicUdiDi>
    <tradeName>00874750005703</tradeName>
    <deviceName>Oro-Nasal Mask</deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:05:29.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750001460</udiDi>
    <basicUdiDi>081713602691293C2</basicUdiDi>
    <tradeName>00874750001460</tradeName>
    <deviceName>Oro-Nasal Mask</deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113560</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:05:27.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750001040</udiDi>
    <basicUdiDi>081713602691178BZ</basicUdiDi>
    <tradeName>00874750001040</tradeName>
    <deviceName>Oro-Nasal Mask</deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201575</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:05:23.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000999</udiDi>
    <basicUdiDi>081713602691236BN</basicUdiDi>
    <tradeName>00874750000999</tradeName>
    <deviceName>Oro-Nasal Mask</deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113490</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:05:22.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750000005</udiDi>
    <basicUdiDi>081713602691241BF</basicUdiDi>
    <tradeName>00874750000005</tradeName>
    <deviceName>Oro-Nasal Mask</deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:05:21.927Z</lastUpdated>
  </row>
</eudamedExport>