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    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000008253</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <reference>FP-810</reference>
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    <lastUpdated>2026-07-05T05:09:50.930Z</lastUpdated>
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    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>CardiMax FX-8400</tradeName>
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    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
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    <udiDi>04538612914324</udiDi>
    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>ECG Interpretation Software</tradeName>
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    <manufacturerName>Fukuda Denshi Co., Ltd.</manufacturerName>
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    <reference>FP-811</reference>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-811S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:50.828Z</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>
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    <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>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-908A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.904Z</lastUpdated>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-908LP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.879Z</lastUpdated>
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    <basicUdiDi>4538612010009E</basicUdiDi>
    <tradeName>CardiMax FX-9800</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>
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    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX-9800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:09:27.852Z</lastUpdated>
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    <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>
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    <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>
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    <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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    <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>
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    <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>
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    <riskClass>Sınıf I</riskClass>
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    <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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    <udiDi>08698870309389</udiDi>
    <basicUdiDi>86988703FMTECGCABLEE2XXVV</basicUdiDi>
    <tradeName>Reusable Patient Monitoring ECG Cable</tradeName>
    <deviceName>Reusable Patient Monitoring ECG Cable</deviceName>
    <manufacturerName>METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022486</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E200-4003/GI</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:49:36.285Z</lastUpdated>
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    <tradeName>Reusable Diagnostic EKG Cable</tradeName>
    <deviceName>Reusable Diagnostic EKG Cable</deviceName>
    <manufacturerName>METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>E100/LNB/I</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:49:33.419Z</lastUpdated>
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    <tradeName>08594214060025</tradeName>
    <deviceName>VDI ECG Cables and Leadwires – reusable</deviceName>
    <manufacturerName>VDI Technologies s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000029098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:51:45.090Z</lastUpdated>
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    <tradeName>ECG LEADWIRE SET</tradeName>
    <deviceName>CS ONE ECG Cable and Leadwires</deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
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    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2066468-005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:46:20.882Z</lastUpdated>
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    <tradeName>Clamp electrode</tradeName>
    <deviceName>ECG Accessories</deviceName>
    <manufacturerName>EF Medica Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000009938</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60.100.02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:59:08.786Z</lastUpdated>
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    <manufacturerName>FIAB S.p.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG922/4TG/RU</reference>
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    <lastUpdated>2026-07-03T04:56:45.332Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
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    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9630028010</reference>
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    <lastUpdated>2026-07-03T04:56:41.324Z</lastUpdated>
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