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    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>CardiMax FX-8300</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX-8300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.953Z</lastUpdated>
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  <row>
    <udiDi>04538612914294</udiDi>
    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>ECG INTERPRETATION SOFTWARE</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-810</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.930Z</lastUpdated>
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    <udiDi>04538612914300</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></emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OTE-05</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.902Z</lastUpdated>
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  <row>
    <udiDi>04538612914317</udiDi>
    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>CardiMax FX-8400</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX-8400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.876Z</lastUpdated>
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  <row>
    <udiDi>04538612914324</udiDi>
    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>ECG Interpretation Software</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-811</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612914331</udiDi>
    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>Stress Test Package</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-811S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.828Z</lastUpdated>
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  <row>
    <udiDi>04538612914379</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>Network 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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJO-17SS2.5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612914447</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Serial Converter 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></emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-756</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.768Z</lastUpdated>
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  <row>
    <udiDi>04538612914454</udiDi>
    <basicUdiDi>4538612022019Z</basicUdiDi>
    <tradeName>SpO2 Cap (For Transmitter)</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></emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAT-04A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612914461</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>Ethernet Branch Cable STP</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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-523A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612914478</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>Ethernet Branch Cable STP</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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-523B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612914485</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>Ethernet Branch Cable STP</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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-523C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.667Z</lastUpdated>
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  <row>
    <udiDi>04538612914492</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>Ethernet Branch Cable STP</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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-523D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612914508</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>Ethernet Branch Cable STP</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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-523E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.616Z</lastUpdated>
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  <row>
    <udiDi>04538612914515</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>LAN Interface Cable STP</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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-533A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.590Z</lastUpdated>
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  <row>
    <udiDi>04538612914522</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>LAN Interface Cable STP</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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-533B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.566Z</lastUpdated>
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  <row>
    <udiDi>04538612914539</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>LAN Interface Cable STP</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></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-533C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.543Z</lastUpdated>
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    <udiDi>04538612914553</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Chart Box</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></emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-53A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.518Z</lastUpdated>
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    <udiDi>04538612914560</udiDi>
    <basicUdiDi>453861203300AB</basicUdiDi>
    <tradeName>PCG Microphone</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></emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MA-300HDS(V)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.490Z</lastUpdated>
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  <row>
    <udiDi>04538612914577</udiDi>
    <basicUdiDi>453861203300AB</basicUdiDi>
    <tradeName>PCG Microphone</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></emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MA-310HDS(V)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.467Z</lastUpdated>
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