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    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-1200 Express</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:44:12.804Z</lastUpdated>
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    <udiDi>06944413800366</udiDi>
    <basicUdiDi>69444138SE12SPJ</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-12 Express</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:44:09.150Z</lastUpdated>
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    <udiDi>06944413800359</udiDi>
    <basicUdiDi>69444138SE12SPJ</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:58.421Z</lastUpdated>
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    <udiDi>06944413800328</udiDi>
    <basicUdiDi>69444138SE3SUC</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-300B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:57.426Z</lastUpdated>
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  <row>
    <udiDi>06944413800311</udiDi>
    <basicUdiDi>69444138SE3SUC</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-300A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:54.857Z</lastUpdated>
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  <row>
    <udiDi>06944413800304</udiDi>
    <basicUdiDi>69444138SE3SUC</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:49.994Z</lastUpdated>
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  <row>
    <udiDi>06944413800298</udiDi>
    <basicUdiDi>69444138SE3SUC</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:43:49.307Z</lastUpdated>
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  <row>
    <udiDi>04538612021237</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Recording paper</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-119TE 63/30M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:26.298Z</lastUpdated>
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    <udiDi>04538612021442</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Recording paper</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-122TE 63/20M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:26.284Z</lastUpdated>
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    <udiDi>04538612023194</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Recording paper</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-358TE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:26.255Z</lastUpdated>
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    <udiDi>04538612026461</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Recording paper</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-382TE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:26.229Z</lastUpdated>
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    <udiDi>04538612027109</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Recording paper</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-618TE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:26.213Z</lastUpdated>
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    <udiDi>04538612028090</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Recording paper</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-69TE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:26.190Z</lastUpdated>
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    <udiDi>04538612040313</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Recording paper</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-222TE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:26.024Z</lastUpdated>
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    <udiDi>04538612044151</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Patient Cables CMS-05 series</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS-05FTA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.880Z</lastUpdated>
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    <udiDi>04538612044359</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Input box attachment belt with buckle</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OBS-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.867Z</lastUpdated>
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    <udiDi>04538612048708</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Serial 8P Straight 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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJS-04DA1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.821Z</lastUpdated>
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    <udiDi>04538612048715</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Serial 8P Straight 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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJS-04DA5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.803Z</lastUpdated>
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    <udiDi>04538612059834</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>PATIENT CABLE HANGER</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>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAE-47A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.317Z</lastUpdated>
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  <row>
    <udiDi>04538612060571</udiDi>
    <basicUdiDi>4538612010019G</basicUdiDi>
    <tradeName>Serial 8P Cross 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>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJS-03DA1-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T18:25:25.297Z</lastUpdated>
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