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    <tradeName>EDAN CADENCE MS1-01921</tradeName>
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    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-CD11290/150RS1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.640Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-CO15290/150R</reference>
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    <lastUpdated>2026-06-21T14:13:44.614Z</lastUpdated>
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    <udiDi>09551019814023</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>EDAN SE-1201</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-NK210140/142RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.589Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-21525/16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.564Z</lastUpdated>
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  <row>
    <udiDi>09551019814047</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>EDAN E1112</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-21525/16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.540Z</lastUpdated>
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    <udiDi>09551019814054</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>ESAOTE P8000I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-S8070/300RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.514Z</lastUpdated>
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    <udiDi>09551019814061</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>ESAOTE 96900 29000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-EB9070/400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.483Z</lastUpdated>
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    <udiDi>09551019814078</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>ESAOTE 96900 11000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-EB126150/170RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.460Z</lastUpdated>
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    <udiDi>09551019814085</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>ESAOTE 96900 11134</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-EB210150/200S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.437Z</lastUpdated>
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  <row>
    <udiDi>09551019814092</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>ESAOTE POWER 8000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-S210280/200RS80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.420Z</lastUpdated>
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  <row>
    <udiDi>09551019814108</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>ESAOTE 96900 23000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-EB210300/200RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.403Z</lastUpdated>
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    <udiDi>09551019814115</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY 050R30-F01</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-5030/16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.386Z</lastUpdated>
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    <udiDi>09551019814122</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY 050R30-F01</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-5030/16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.374Z</lastUpdated>
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    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY 063R30-H01</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-6330/16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.362Z</lastUpdated>
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    <udiDi>09551019814146</udiDi>
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    <tradeName>FUKUDA CARDISUNY 063R30-H01</tradeName>
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    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-6330/16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.352Z</lastUpdated>
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    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-FC63100/300RS1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.335Z</lastUpdated>
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    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-13030/16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.313Z</lastUpdated>
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    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-13030/16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.289Z</lastUpdated>
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    <tradeName>FUKUDA CARDISUNY 130F50-H02</tradeName>
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    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-FC13070/666RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.270Z</lastUpdated>
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    <manufacturerName>ISD MEDITECH SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000043531</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12059009</emdnCode>
    <emdnDescription>ECG DATA MANAGEMENT SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC-FC145150/400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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