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<eudamedExport entity="devices">
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    <udiDi>04015672113558</udiDi>
    <basicUdiDi>4015672113555D</basicUdiDi>
    <tradeName>04015672113558</tradeName>
    <deviceName>HV-F021-E4SL</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-E4SL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:47:40.803Z</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>
  </row>
  <row>
    <udiDi>04015672110885</udiDi>
    <basicUdiDi>4015672110885D</basicUdiDi>
    <tradeName>HeatTens (HV-F311-E)</tradeName>
    <deviceName>HeatTens</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>HeatTens (HV-F311-E)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:45:22.220Z</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>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>03760071201481</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Duo Sport 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS2FR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071201597</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Pinktens</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2P_UNI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071201603</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Pinktens</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2P_FR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071201610</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Duo Care</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2M_AFS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071201627</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Duo Sport 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS2UNI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071201665</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Bluetens Classic 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2UNI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071201689</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Bluetens Classic 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2FR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071201924</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Bluetens Classic 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071201931</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Duo Sport 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS2AFS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071201948</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Pinktens</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760071202181</udiDi>
    <basicUdiDi>3760071CL2A2</basicUdiDi>
    <tradeName>Duo Care</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bluetens limited</manufacturerName>
    <manufacturerSrn>CN-MF-000021806</manufacturerSrn>
    <authorisedRepresentativeName>S4M EUROPE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000180</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060073970339</udiDi>
    <basicUdiDi>506007397MYO24PAR</basicUdiDi>
    <tradeName>NeuroTrac® MyoPlus4 Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Verity Medical Ltd.</manufacturerName>
    <manufacturerSrn>IE-MF-000007426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYO420P</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:45:43.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060073970544</udiDi>
    <basicUdiDi>506007397ETS2004C</basicUdiDi>
    <tradeName>Kegel8®Ultra</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Verity Medical Ltd.</manufacturerName>
    <manufacturerSrn>IE-MF-000007426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPH200</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:45:43.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060073970568</udiDi>
    <basicUdiDi>506007397C6V350SR</basicUdiDi>
    <tradeName>Zimmer MultiTens</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Verity Medical Ltd.</manufacturerName>
    <manufacturerSrn>IE-MF-000007426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6V350ZM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:45:43.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060073970582</udiDi>
    <basicUdiDi>506007397ECS300AZ5</basicUdiDi>
    <tradeName>Universal TENS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Verity Medical Ltd.</manufacturerName>
    <manufacturerSrn>IE-MF-000007426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12062899</emdnCode>
    <emdnDescription>NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPH300A</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:45:43.596Z</lastUpdated>
  </row>
</eudamedExport>