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<eudamedExport entity="devices">
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    <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>
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    <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>
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    <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>
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  <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>
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  <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>
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  <row>
    <udiDi>04015672109056</udiDi>
    <basicUdiDi>4015672109055M</basicUdiDi>
    <tradeName>Intelli Cuff HEM-FL31 (HEM-FL31-E)</tradeName>
    <deviceName>Intelli Cuff HEM-FL31</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>Intelli Cuff HEM-FL31 (HEM-FL31-E)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:35.761Z</lastUpdated>
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  <row>
    <udiDi>04015672109049</udiDi>
    <basicUdiDi>4015672109045K</basicUdiDi>
    <tradeName>Easy Cuff HEM-RML31 (HEM-RML31-E)</tradeName>
    <deviceName>Easy Cuff HEM-RML31</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-RML31-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:34.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672108028</udiDi>
    <basicUdiDi>4015672108025A</basicUdiDi>
    <tradeName>04015672108028</tradeName>
    <deviceName>Air tube (1.3m)</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-TUBE-130CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:33.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672108011</udiDi>
    <basicUdiDi>40156721080158</basicUdiDi>
    <tradeName>04015672108011</tradeName>
    <deviceName>Air tube (1.0m)</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-TUBE-100CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:31.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672107885</udiDi>
    <basicUdiDi>40156721078869</basicUdiDi>
    <tradeName>PROBE COVER MC-EP2 (MC-EP2-E)</tradeName>
    <deviceName>PROBE COVER MC-EP2</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>V030180</emdnCode>
    <emdnDescription>BODY TEMPERATURE MEASURING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC-EP2-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:29.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672107878</udiDi>
    <basicUdiDi>40156721078767</basicUdiDi>
    <tradeName>AC-ADAPTER-E1600 (HXA-AC-1300E)</tradeName>
    <deviceName>AC-ADAPTER-E1600</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>Z129080</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HXA-AC-1300E</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:27.741Z</lastUpdated>
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  <row>
    <udiDi>04015672107809</udiDi>
    <basicUdiDi>4015672107805R</basicUdiDi>
    <tradeName>Gentle Temp 521 (MC-521-E)</tradeName>
    <deviceName>Gentle Temp 521</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>V0301010299</emdnCode>
    <emdnDescription>DIGITAL THERMOMETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC-521-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:26.957Z</lastUpdated>
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  <row>
    <udiDi>04015672107793</udiDi>
    <basicUdiDi>40156721077968</basicUdiDi>
    <tradeName>Gentle Temp 520 (MC-520-E)</tradeName>
    <deviceName>Gentle Temp 520</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>V0301010299</emdnCode>
    <emdnDescription>DIGITAL THERMOMETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC-520-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:25.341Z</lastUpdated>
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    <udiDi>04015672107267</udiDi>
    <basicUdiDi>4015672107265K</basicUdiDi>
    <tradeName>GS CUFF SS (HXA-GCUFF-SSLB)</tradeName>
    <deviceName>GS CUFF SS</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>HXA-GCUFF-SSLB</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:22.937Z</lastUpdated>
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    <udiDi>04015672107250</udiDi>
    <basicUdiDi>4015672107255H</basicUdiDi>
    <tradeName>GS CUFF S (HXA-GCUFF-SLB)</tradeName>
    <deviceName>GS CUFF S</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>HXA-GCUFF-SLB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:21.376Z</lastUpdated>
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    <udiDi>04015672107243</udiDi>
    <basicUdiDi>4015672107245F</basicUdiDi>
    <tradeName>GS CUFF M (HXA-GCUFF-MLB)</tradeName>
    <deviceName>GS CUFF M</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>Z1203020302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:20.541Z</lastUpdated>
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    <udiDi>04015672107236</udiDi>
    <basicUdiDi>4015672107235D</basicUdiDi>
    <tradeName>GS CUFF L (HXA-GCUFF-LLB)</tradeName>
    <deviceName>GS CUFF L</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>HXA-GCUFF-LLB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:18.932Z</lastUpdated>
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    <udiDi>04015672107229</udiDi>
    <basicUdiDi>4015672107225B</basicUdiDi>
    <tradeName>GS CUFF XL (HXA-GCUFF-XLLB)</tradeName>
    <deviceName>GS CUFF XL</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>HXA-GCUFF-XLLB</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:44:16.533Z</lastUpdated>
  </row>
</eudamedExport>