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<eudamedExport entity="devices">
  <row>
    <udiDi>04538612916489</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>All Purpose Blood Pressure 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>MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUF-1000-L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612916496</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>All Purpose Blood Pressure 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>MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUF-1000-XL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612916502</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Thermometer 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>MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-125A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612916540</udiDi>
    <basicUdiDi>4538612020019P</basicUdiDi>
    <tradeName>Thermometer 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></emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJO-32RS0.1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612908828</udiDi>
    <basicUdiDi>4538612020009M</basicUdiDi>
    <tradeName>DYNASCOPE 8000 series DS-8500 system</tradeName>
    <deviceName>Measuring and Monitoring Device for Vital Signs</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSC-8510</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:58.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612908262</udiDi>
    <basicUdiDi>4538612021009S</basicUdiDi>
    <tradeName>Central Telemetry Receiver</tradeName>
    <deviceName>Measuring and Monitoring Device for Vital Signs</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LW-7080</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:57.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612907739</udiDi>
    <basicUdiDi>4538612022009X</basicUdiDi>
    <tradeName>ECG, Respiration and SpO2 Transmitter, model LX-7230N, LX-7230KM</tradeName>
    <deviceName>Measuring and Monitoring Equipment for Vital Signs</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX-7230N</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:56.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612907395</udiDi>
    <basicUdiDi>453861204100A8</basicUdiDi>
    <tradeName>DynaBase</tradeName>
    <deviceName>VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVW-6000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:56.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612905858</udiDi>
    <basicUdiDi>453861204000A3</basicUdiDi>
    <tradeName>ECG Filing S/W</tradeName>
    <deviceName>ECG DATA MANAGEMENT SYSTEMS</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EFS-200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:55.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612311628</udiDi>
    <basicUdiDi>4538612011019M</basicUdiDi>
    <tradeName>Connection Cable</tradeName>
    <deviceName>Accessories for Sphygmomanometer and Sphygmograph</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJV-03SS2.5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:54.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612230332</udiDi>
    <basicUdiDi>453861202301A6</basicUdiDi>
    <tradeName>Mounting Bracket for LW-1000</tradeName>
    <deviceName>Reusable Accessories Measuring and Monitoring Device for Vital Signs</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VITAL SIGNS TELEMETRY RECEIVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAO-1012A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:53.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612100970</udiDi>
    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>ECG AMP Module</tradeName>
    <deviceName>Electrocardiograph</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EE-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:52.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612061844</udiDi>
    <basicUdiDi>4538612031009Z</basicUdiDi>
    <tradeName>ECG Relay Cable CIT-13DIN series</tradeName>
    <deviceName>Electrical-only medical device connection cable, reusable</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VVARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIT-13DIN3-0.3U</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:52.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612054181</udiDi>
    <basicUdiDi>4538612022019Z</basicUdiDi>
    <tradeName>Disposable Portable Case</tradeName>
    <deviceName>Accessories for Measuring and Monitoring Equipment for Vital Signs</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-720D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:51.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612052361</udiDi>
    <basicUdiDi>453861203500AM</basicUdiDi>
    <tradeName>ECG ELECTRODES</tradeName>
    <deviceName>Electrocardiographic electrode, single-use</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TEO-174DCR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:50.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612040504</udiDi>
    <basicUdiDi>453861203300AB</basicUdiDi>
    <tradeName>PCG Microphone</tradeName>
    <deviceName>Electroacoustic transducer</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MA-300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:49.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612040207</udiDi>
    <basicUdiDi>4538612030009U</basicUdiDi>
    <tradeName>Patient Cable</tradeName>
    <deviceName>Electrocardiographic lead set, reusable</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMF-700-3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:48.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612028748</udiDi>
    <basicUdiDi>453861203400AG</basicUdiDi>
    <tradeName>Chest Electrodes TE-01 series</tradeName>
    <deviceName>Electrocardiographic electrode</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE-01U</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:48.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612014833</udiDi>
    <basicUdiDi>4538612021019U</basicUdiDi>
    <tradeName>Connection Cable</tradeName>
    <deviceName>Accessories for Measuring and Monitoring Device for Vital Signs</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CENTRAL INFORMATION COMPUTING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-530A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:47.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612014338</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Serial Cross Cable</tradeName>
    <deviceName>Accessories for Electrocardiograph</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ-325</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:44:45.668Z</lastUpdated>
  </row>
</eudamedExport>