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<eudamedExport entity="devices">
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    <basicUdiDi>4538612020009M</basicUdiDi>
    <tradeName>Recorder/Expansion Port Unit</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-811</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910494</udiDi>
    <basicUdiDi>4538612020009M</basicUdiDi>
    <tradeName>Expansion Port Unit</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CU-810</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910500</udiDi>
    <basicUdiDi>4538612020009M</basicUdiDi>
    <tradeName>Base Unit</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-8210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910517</udiDi>
    <basicUdiDi>4538612020009M</basicUdiDi>
    <tradeName>HS Adapter</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSB-80</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910524</udiDi>
    <basicUdiDi>4538612020009M</basicUdiDi>
    <tradeName>Display Unit</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC-8210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910685</udiDi>
    <basicUdiDi>4538612020009M</basicUdiDi>
    <tradeName>BISx I/F Unit</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBX-800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910692</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Countertop for DS-8200</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-68A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910708</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Bed Mount for DS-8200</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-69A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910715</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>GCX Attachment for Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-70A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910722</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>VESA Attachment for LC-8210</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-71A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910739</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Gas Unit / External Output Box 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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-72A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910753</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Recorder Mounting Bracket for Countertop</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-74A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910784</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>HLX-801 Installation 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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAT-02A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910791</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Rail/Pole Clamp for DS-8100 (VESA75mm)</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-84A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910807</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Bed Mount for DS-8100 (VESA75mm)</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-85A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910814</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>HCP Fixing Bracket for DS-8100</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-86A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910821</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Counter Bracket (for OAO-66A)</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-87A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910852</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Clip Bracket for DS-8100</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-90A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910869</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Module Connection 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>Z1203020201</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJO-13SS1.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612910876</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Module Connection 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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJO-13SS3.5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:53.406Z</lastUpdated>
  </row>
</eudamedExport>