<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09551026270119</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</basicUdiDi>
    <tradeName>EDAN ECG ROLL (80MM X 20M)</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>SK-8020-13R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270126</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</basicUdiDi>
    <tradeName>EDAN ECG ROLL (80MM X 25M)</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>SK-8025-13R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270133</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</basicUdiDi>
    <tradeName>EDAN SE-601B</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>SK-FD110140-142RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270140</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</basicUdiDi>
    <tradeName>EDAN M25R-75112</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>SK-CO15290-150R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270188</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</basicUdiDi>
    <tradeName>EDAN SE-1201</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>SK-NK210140-142RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270195</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-S8070-300RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270201</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-EB9070-400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270218</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-EB126150-170RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270225</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-EB210150-200S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270232</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-S210280-200RS80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270249</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-EB210300-200RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270256</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-FC63100-300RS1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270263</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-13030-16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270270</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-13030-16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270287</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-FC13070-666RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270294</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-FC145150-400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270300</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-FC210150-400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270317</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</basicUdiDi>
    <tradeName>FUKUDA DENSHI OP-119TE</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>SK-FD6330-16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270324</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</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>SK-FD5075-400RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551026270331</udiDi>
    <basicUdiDi>955102627MCRP-SMMG</basicUdiDi>
    <tradeName>FUKUDA DENSHI OP-124TE</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>SK-FD5075-400S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:03:42.272Z</lastUpdated>
  </row>
</eudamedExport>