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<eudamedExport entity="devices">
  <row>
    <udiDi>04538612044151</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Patient Cables CMS-05 series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS-05FTA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612044359</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Input box attachment belt with buckle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OBS-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612048708</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Serial 8P Straight Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJS-04DA1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612048715</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Serial 8P Straight Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJS-04DA5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612059834</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>PATIENT CABLE HANGER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-47A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612060571</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Serial 8P Cross Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJS-03DA1-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612060588</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Serial 8P Cross Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJS-03DA5-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612100635</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>SD Card</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-2G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612100802</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Card Reader Mounting Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-50A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612100963</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Trolley</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OTE-10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612100994</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Printing Paper Wire Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-58A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612101007</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Back Side Cable Cover</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-57A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612101021</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Storage Drawer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-61A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612101045</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>SD CARD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-2G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612101052</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Li-ion Battery Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTE-004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612101106</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>WPM Dock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-63A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612121234</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Li-ion BATTERY PACK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTE-002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612121753</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Li-ion Battery Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTE-001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612122460</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>15-lead Patient Cable Hanger Attachment</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-51A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612122576</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Basket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-52A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:24.783Z</lastUpdated>
  </row>
</eudamedExport>