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    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Patient Cable CME-77</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>CME-77FJKU-W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.662Z</lastUpdated>
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  <row>
    <udiDi>04538612915406</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Patient Cable CME-03</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>CME-03FTAU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:28.639Z</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>Z12050301</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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    <udiDi>04538612915987</udiDi>
    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>Wireless Patient Module</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>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIE-01B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612916007</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>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-908A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>04538612916014</udiDi>
    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>LP Testing 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>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-908LP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.879Z</lastUpdated>
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  <row>
    <udiDi>04538612916021</udiDi>
    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>CardiMax FX-9800</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>Z12050380</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX-9800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698870384348</udiDi>
    <basicUdiDi>86988703FMTECGCABLEE2XXVV</basicUdiDi>
    <tradeName>Reusable Patient Monitoring ECG Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022486</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E204-5010/0I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:07.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698870384331</udiDi>
    <basicUdiDi>86988703FMTEKGECGLEADR7</basicUdiDi>
    <tradeName>Reusable EKG / ECG Leadwire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022486</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E118BI/5B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:05.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095916292</udiDi>
    <basicUdiDi>890209591629HK</basicUdiDi>
    <tradeName>Right Atrial ECG Adaptor With or Without Cable</tradeName>
    <deviceName>Right Atrial ECG Adaptor With or Without Cable</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000003380</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050385</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91629</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:24:30.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809877250035</udiDi>
    <basicUdiDi>880987725ECGBUDDYFL</basicUdiDi>
    <tradeName>ECG Buddy</tradeName>
    <deviceName>ECG Buddy</deviceName>
    <manufacturerName>ARPI Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000044471</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050392</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG Buddy-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:00:29.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809276943972</udiDi>
    <basicUdiDi>880927694CP1SW</basicUdiDi>
    <tradeName>08809276943972</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Bionet Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000013439</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>many</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:49:41.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809276943958</udiDi>
    <basicUdiDi>880927694CQ57NE</basicUdiDi>
    <tradeName>Cardio Q50</tradeName>
    <deviceName>Electrocardiographs &amp; Spirometers</deviceName>
    <manufacturerName>Bionet Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000013439</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>many</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:49:39.561Z</lastUpdated>
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  <row>
    <udiDi>08809276943552</udiDi>
    <basicUdiDi>880927694C72C</basicUdiDi>
    <tradeName>08809276943552</tradeName>
    <deviceName>Electrocardiographs &amp; Spirometers</deviceName>
    <manufacturerName>Bionet Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000013439</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>many</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:49:37.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045800229</udiDi>
    <basicUdiDi>88000458HTPY5</basicUdiDi>
    <tradeName>08800045800229</tradeName>
    <deviceName>HATIV P30</deviceName>
    <manufacturerName>VUNO Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022266</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hativ P30A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:06.052Z</lastUpdated>
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  <row>
    <udiDi>08720892412805</udiDi>
    <basicUdiDi>87208924128CordysCPY8</basicUdiDi>
    <tradeName>08720892412805</tradeName>
    <deviceName>Galvo 12L</deviceName>
    <manufacturerName>Cordys Analytics BV</manufacturerName>
    <manufacturerSrn>NL-MF-000040718</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050392</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ART1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:08:15.785Z</lastUpdated>
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  <row>
    <udiDi>08720892000019</udiDi>
    <basicUdiDi>8720892SPA2099T1v14Z</basicUdiDi>
    <tradeName>SPA2099 T1 / v1.0</tradeName>
    <deviceName>T-shirt SPA2099 with integrated electrodes</deviceName>
    <manufacturerName>SPA2099 B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000047084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPA2099-T1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:06:32.415Z</lastUpdated>
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  <row>
    <udiDi>87175246406370</udiDi>
    <basicUdiDi>871752464950920UG</basicUdiDi>
    <tradeName>Lode ECG Streamer</tradeName>
    <deviceName>ECG Streamer</deviceName>
    <manufacturerName>Lode B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001493</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950920</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:30:20.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698870330994</udiDi>
    <basicUdiDi>86988703FMTEKGECGLEADR7</basicUdiDi>
    <tradeName>Reusable EKG / ECG Leadwire</tradeName>
    <deviceName>Reusable EKG / ECG Leadwire</deviceName>
    <manufacturerName>METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022486</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HL01-07</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:50:07.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698870320872</udiDi>
    <basicUdiDi>86988703FMTEKGACCESSORYEW</basicUdiDi>
    <tradeName>Reusable EKG Suction Electrode</tradeName>
    <deviceName>EKG Accessories</deviceName>
    <manufacturerName>METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022486</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:49:40.324Z</lastUpdated>
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