<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04015672110564</udiDi>
    <basicUdiDi>4015672110564Y</basicUdiDi>
    <tradeName>HEM-RXL31 (HEM-RXL31-E)</tradeName>
    <deviceName>HEM-RXL31</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM-RXL31-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:21.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672110496</udiDi>
    <basicUdiDi>40156721104953</basicUdiDi>
    <tradeName>Supply medication set</tradeName>
    <deviceName>Supply medication set</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Supply medication set</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:19.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672110472</udiDi>
    <basicUdiDi>4015672110474X</basicUdiDi>
    <tradeName>Air filter (U17-4P2-E)</tradeName>
    <deviceName>Air filter</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U17-4P2-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:17.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672110465</udiDi>
    <basicUdiDi>4015672110464V</basicUdiDi>
    <tradeName>EVOLV (HEM-7600T-E)</tradeName>
    <deviceName>EVOLV</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM-7600T-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:15.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672110298</udiDi>
    <basicUdiDi>4015672110294V</basicUdiDi>
    <tradeName>E3 Intense (HV-F021-EW)</tradeName>
    <deviceName>E3 Intense</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HV-F021-EW</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:15.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109940</udiDi>
    <basicUdiDi>4015672109946E</basicUdiDi>
    <tradeName>Mouthpiece set (NEB-MPSS-78E)</tradeName>
    <deviceName>Mouthpiece set</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-MPSS-78E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:13.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109933</udiDi>
    <basicUdiDi>4015672109936C</basicUdiDi>
    <tradeName>Inhalation Hose (NEB-HS-L15E)</tradeName>
    <deviceName>Inhalation Hose</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-HS-L15E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:11.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109926</udiDi>
    <basicUdiDi>4015672109926A</basicUdiDi>
    <tradeName>Inhalation Hose (NEB-HS-L70E)</tradeName>
    <deviceName>Inhalation Hose</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-HS-L70E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:09.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109919</udiDi>
    <basicUdiDi>40156721099168</basicUdiDi>
    <tradeName>Inhalation mask set (NEB-MSILS-78E)</tradeName>
    <deviceName>Inhalation mask set</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-MSILS-78E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:08.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109902</udiDi>
    <basicUdiDi>40156721099066</basicUdiDi>
    <tradeName>Inhalation mask set (NEB-MSISS-78E)</tradeName>
    <deviceName>Inhalation mask set</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-MSISS-78E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:07.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109896</udiDi>
    <basicUdiDi>4015672109896M</basicUdiDi>
    <tradeName>Long time Nebulization Set (NEB-LMCC-78E)</tradeName>
    <deviceName>Long time Nebulization Set</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-LMCC-78E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:04.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109872</udiDi>
    <basicUdiDi>4015672109876H</basicUdiDi>
    <tradeName>Air Filter set (NEB-AFS-78E)</tradeName>
    <deviceName>NEB-AFS-78E</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9300390-4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:03.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109865</udiDi>
    <basicUdiDi>4015672109866F</basicUdiDi>
    <tradeName>Silicon Packing (NEB-SP-78E)</tradeName>
    <deviceName>Silicon Packing</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-SP-78E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:02.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109858</udiDi>
    <basicUdiDi>4015672109856D</basicUdiDi>
    <tradeName>NEB-RWT-78E</tradeName>
    <deviceName>NEB-RWT-78E</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-RWT-78E</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:00.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109841</udiDi>
    <basicUdiDi>4015672109846B</basicUdiDi>
    <tradeName>Nebulization set (NEB-NZU-78E)</tradeName>
    <deviceName>Nebulization set</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-NZU-78E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:58.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109551</udiDi>
    <basicUdiDi>40156721095564</basicUdiDi>
    <tradeName>NE-U780 (NE-U780-E)</tradeName>
    <deviceName>NE-U780</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-U780-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:56.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109827</udiDi>
    <basicUdiDi>40156721098267</basicUdiDi>
    <tradeName>Nebulizer Kit Set (NEB-NSET1-90E)</tradeName>
    <deviceName>NEB-NSET1-90E</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9701325-4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:55.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109377</udiDi>
    <basicUdiDi>40156721093762</basicUdiDi>
    <tradeName>COMP AIR Basic (NE-C803-UK)</tradeName>
    <deviceName>COMP AIR Basic</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-C803-UK</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:54.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109537</udiDi>
    <basicUdiDi>4015672109535Y</basicUdiDi>
    <tradeName>E3 Intense (HV-F021-ESL)</tradeName>
    <deviceName>E3 Intense</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E3 Intense (HV-F021-ESL)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:51.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672109353</udiDi>
    <basicUdiDi>4015672109355W</basicUdiDi>
    <tradeName>COMP AIR Basic (NE-C803-E)</tradeName>
    <deviceName>COMP AIR Basic</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-C803-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:38.147Z</lastUpdated>
  </row>
</eudamedExport>