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<eudamedExport entity="devices">
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    <udiDi>04015672112063</udiDi>
    <basicUdiDi>4015672112064T</basicUdiDi>
    <tradeName>X4 Smart (HEM-7155T-ESL)</tradeName>
    <deviceName>X4 Smart</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-7155T-ESL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:47:02.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672111974</udiDi>
    <basicUdiDi>4015672111975K</basicUdiDi>
    <tradeName>Infant Mask (NEB-MSSP-E)</tradeName>
    <deviceName>Infant Mask</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-MSSP-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:59.986Z</lastUpdated>
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    <udiDi>04015672111837</udiDi>
    <basicUdiDi>40156721118358</basicUdiDi>
    <tradeName>M3 (HEM-7154-E)</tradeName>
    <deviceName>M3</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-7154-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:58.394Z</lastUpdated>
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    <udiDi>04015672111950</udiDi>
    <basicUdiDi>4015672111955F</basicUdiDi>
    <tradeName>Medication cup (U12-1-E)</tradeName>
    <deviceName>Medication cup</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>U12-1-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:57.590Z</lastUpdated>
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    <udiDi>04015672111806</udiDi>
    <basicUdiDi>40156721118052</basicUdiDi>
    <tradeName>M3 Comfort (HEM-7155-E)</tradeName>
    <deviceName>M3 Comfort</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-7155-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:55.987Z</lastUpdated>
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  <row>
    <udiDi>04015672111813</udiDi>
    <basicUdiDi>40156721118154</basicUdiDi>
    <tradeName>M400 Comfort (HEM-7155-D)</tradeName>
    <deviceName>M400 Comfort</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-7155-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:53.690Z</lastUpdated>
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    <udiDi>04015672111783</udiDi>
    <basicUdiDi>4015672111785F</basicUdiDi>
    <tradeName>M400 Intelli IT (HEM-7155T-D)</tradeName>
    <deviceName>M400 Intelli IT</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-7155T-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:39.919Z</lastUpdated>
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  <row>
    <udiDi>04015672111776</udiDi>
    <basicUdiDi>4015672111775D</basicUdiDi>
    <tradeName>M4 Intelli IT (HEM-7155T-EBK)</tradeName>
    <deviceName>M4 Intelli IT</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-7155T-EBK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:37.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672111745</udiDi>
    <basicUdiDi>40156721117457</basicUdiDi>
    <tradeName>M6 Comfort (HEM-7360-E)</tradeName>
    <deviceName>M6 Comfort</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-7360-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:35.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672111738</udiDi>
    <basicUdiDi>40156721117355</basicUdiDi>
    <tradeName>M500 Intelli IT (HEM-7361T-D)</tradeName>
    <deviceName>M500 Intelli IT</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-7361T-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:35.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672111721</udiDi>
    <basicUdiDi>40156721117253</basicUdiDi>
    <tradeName>M7 Intelli IT (HEM-7361T-EBK)</tradeName>
    <deviceName>M7 Intelli IT</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-7361T-EBK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:33.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672111677</udiDi>
    <basicUdiDi>4015672111675A</basicUdiDi>
    <tradeName>HHP-CM01 (HHP-CM01-E)</tradeName>
    <deviceName>HHP-CM01</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>HHP-CM01-E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:31.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672111660</udiDi>
    <basicUdiDi>40156721116658</basicUdiDi>
    <tradeName>PocketTens (HV-F013-E)</tradeName>
    <deviceName>PocketTens</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>PocketTens (HV-F013-E)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:29.516Z</lastUpdated>
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    <udiDi>04015672111639</udiDi>
    <basicUdiDi>40156721116352</basicUdiDi>
    <tradeName>GS CUFF2 XL (HXA-GCFXL-PCE)</tradeName>
    <deviceName>GS CUFF2 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-GCFXL-PCE</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:28.718Z</lastUpdated>
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    <udiDi>04015672111622</udiDi>
    <basicUdiDi>4015672111624Y</basicUdiDi>
    <tradeName>GS CUFF2 L (HXA-GCFL-PCE)</tradeName>
    <deviceName>GS CUFF2 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-GCFL-PCE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:27.117Z</lastUpdated>
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    <udiDi>04015672111615</udiDi>
    <basicUdiDi>4015672111614W</basicUdiDi>
    <tradeName>GS CUFF2 M (HXA-GCFM-PCE)</tradeName>
    <deviceName>GS CUFF2 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>HXA-GCFM-PCE</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:24.712Z</lastUpdated>
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    <udiDi>04015672111608</udiDi>
    <basicUdiDi>4015672111604U</basicUdiDi>
    <tradeName>GS CUFF2 S (HXA-GCFS-PCE)</tradeName>
    <deviceName>GS CUFF2 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-GCFS-PCE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:23.111Z</lastUpdated>
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    <udiDi>04015672111592</udiDi>
    <basicUdiDi>4015672111595B</basicUdiDi>
    <tradeName>GS CUFF2 SS (HXA-GCFSS-PCE)</tradeName>
    <deviceName>GS CUFF2 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-GCFSS-PCE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:22.312Z</lastUpdated>
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    <udiDi>04015672111585</udiDi>
    <basicUdiDi>40156721115859</basicUdiDi>
    <tradeName>GS CUFF2 XL (HXA-GCFXL-PBE)</tradeName>
    <deviceName>GS CUFF2 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-GCFXL-PBE</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:20.712Z</lastUpdated>
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    <udiDi>04015672111578</udiDi>
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    <tradeName>GS CUFF2 L (HXA-GCFL-PBE)</tradeName>
    <deviceName>GS CUFF2 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-GCFL-PBE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:46:18.337Z</lastUpdated>
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