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    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <reference>CUF-250S-LA</reference>
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    <lastUpdated>2026-07-05T05:09:28.472Z</lastUpdated>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
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    <emdnCode></emdnCode>
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    <reference>CUF-250M-LB</reference>
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    <tradeName>NIBP Cuff</tradeName>
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    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUF-250M-RA</reference>
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    <tradeName>NIBP Cuff</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>CUF-250M-LA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.366Z</lastUpdated>
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    <tradeName>NIBP Cuff</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>ANEROID SPHYGMOMANOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUF-250L-RB</reference>
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    <tradeName>NIBP Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <reference>CUF-250L-LB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>NIBP Cuff</tradeName>
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    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUF-250L-RA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <basicUdiDi>4538612011019M</basicUdiDi>
    <tradeName>NIBP Cuff</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>CUF-250L-LA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.259Z</lastUpdated>
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    <udiDi>04538612915734</udiDi>
    <basicUdiDi>4538612011019M</basicUdiDi>
    <tradeName>Four Limbs NIBP 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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASV-05H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.231Z</lastUpdated>
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    <udiDi>04538612915741</udiDi>
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    <tradeName>Toe Blood Pressure 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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASV-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.192Z</lastUpdated>
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    <udiDi>04538612915789</udiDi>
    <basicUdiDi>4538612021009S</basicUdiDi>
    <tradeName>DYNASCOPE 1000 Series DS-1800 System</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></emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-1800L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.169Z</lastUpdated>
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    <udiDi>04538612915796</udiDi>
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    <tradeName>DYNASCOPE 1000 Series DS-1800 System</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></emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-1800LRE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.143Z</lastUpdated>
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    <udiDi>04538612915802</udiDi>
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    <tradeName>DYNASCOPE 1000 Series DS-1800 System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-1812</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>DYNASCOPE 1000 Series DS-1800 System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-1812RE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>DYNASCOPE 1000 Series DS-1800 System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-1800LR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>04538612915871</udiDi>
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    <tradeName>DYNASCOPE 1000 Series DS-1800 System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-1812R</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.045Z</lastUpdated>
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    <udiDi>04538612915918</udiDi>
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    <tradeName>Central Telemetry Receiver LW-1000</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>
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    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.016Z</lastUpdated>
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    <udiDi>04538612915932</udiDi>
    <basicUdiDi>453861204000A3</basicUdiDi>
    <tradeName>Data Management System</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>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EFS-1000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.990Z</lastUpdated>
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    <udiDi>04538612915949</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Keyboard Holder</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>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-65A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.964Z</lastUpdated>
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