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    <basicUdiDi>955101981MCRPAPH3</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>APP-EB210300-200RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819394</udiDi>
    <basicUdiDi>955101981MCRPAPH3</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>APP-EB9070-400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819400</udiDi>
    <basicUdiDi>955101981MCRPAPH3</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>APP-S210280-200RS80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819417</udiDi>
    <basicUdiDi>955101981MCRPAPH3</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>APP-S8070-300RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819424</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY ECG ROLL (50MM X 30M)</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>APP-5030-16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819431</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY ECG ROLL (50MM X 30M)</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>APP-5030-16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819448</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY ECG ROLL (63MM X 30M)</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>APP-6330-16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819455</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY ECG ROLL (63MM X 30M)</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>APP-6330-16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819462</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY ECG ROLL (130MM X 30M)</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>APP-13030-16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819479</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY ECG ROLL (130MM X 30M)</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>APP-13030-16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819486</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY 130F50-H02</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>APP-FC13070-666RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819493</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY 145F60-H05</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>APP-FC145150-400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819509</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY 210F60-H05</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>APP-FC210150-400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819516</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA CARDISUNY 063F30-H03/OP-219TE</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>APP-FC63100-300RS1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819523</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA DENSHI ECG ROLL (210MM X 30M)</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>APP-21030-16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819530</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA DENSHI OP-219TE/063F30-H03</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>APP-FC63100-300RS1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819547</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA DENSHI OP-222TE</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>APP-FD110140-142RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819554</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA DENSHI OP-358TE</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>APP-FD14530-16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819561</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA DENSHI OP-372TE</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>APP-FD210300-300RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019819578</udiDi>
    <basicUdiDi>955101981MCRPAPH3</basicUdiDi>
    <tradeName>FUKUDA DENSHI OP-115TE</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>APP-FD5075-400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:24.082Z</lastUpdated>
  </row>
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