<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00859584006003</udiDi>
    <basicUdiDi>0859584006KinesiaWG</basicUdiDi>
    <tradeName>00859584006003</tradeName>
    <deviceName>Kinesia ONE</deviceName>
    <manufacturerName>Great Lakes NeuroTechnologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031444</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W01010899</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Kinesia ONE 700-0019</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:49:22.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809446080131</udiDi>
    <basicUdiDi>880944608BSX0X0PL</basicUdiDi>
    <tradeName>08809446080131</tradeName>
    <deviceName>careSTART™ S1 Analyzer</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010899</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSA-E00182</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:12.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859584006034</udiDi>
    <basicUdiDi>0859584006KinesiaWG</basicUdiDi>
    <tradeName>00859584006034</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Great Lakes NeuroTechnologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031444</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W01010899</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Kinesia One  700-0019-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:59.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859584006058</udiDi>
    <basicUdiDi>0859584006KinesiaWG</basicUdiDi>
    <tradeName>00859584006058</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Great Lakes NeuroTechnologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031444</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W01010899</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Kinesia 360 700-0019-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:59.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859584006096</udiDi>
    <basicUdiDi>0859584006KinesiaWG</basicUdiDi>
    <tradeName>00859584006096</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Great Lakes NeuroTechnologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031444</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W01010899</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Kinesia U 700-0025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:59.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859584006102</udiDi>
    <basicUdiDi>0859584006KinesiaWG</basicUdiDi>
    <tradeName>00859584006102</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Great Lakes NeuroTechnologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031444</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W01010899</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Kinesia U - 700-0026</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:59.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859584006256</udiDi>
    <basicUdiDi>0859584006KinesiaWG</basicUdiDi>
    <tradeName>00859584006256</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Great Lakes NeuroTechnologies Inc</manufacturerName>
    <manufacturerSrn>US-MF-000031444</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W01010899</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Kinesia 360 - 700-0020-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:59.476Z</lastUpdated>
  </row>
</eudamedExport>