<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09551019813705</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CARDIETTE / CARDIOLINE 660 100 42</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-CA210280/200BS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:45.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813712</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CARDIETTE / CARDIOLINE 874 3560</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-6030/16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:45.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813729</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CARDIETTE / CARDIOLINE 874 3560</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-6030/16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:45.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813736</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CARDIETTE / CARDIOLINE 874 5558</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-CA60100/300RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:45.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813743</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CARDIETTE / CARDIOLINE 874 5554</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-CA112100/300RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:45.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813750</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CARDIETTE / CARDIOLINE 200S/200+</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-CA210295/180RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:45.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813767</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CARDIETTE / CARDIOLINE 100S/100+</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-CA100150/180RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:45.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813774</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CAREWELL 1101/1101G</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>2026-06-21T14:13:45.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813781</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CAREWELL 1101/1101G</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>2026-06-21T14:13:44.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813798</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CAREWELL 1103/1103LW</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-8025/13R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813804</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CAREWELL 1103/1103LW</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-8025/13R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813811</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CAREWELL 1106/ASPEL ASCARD A4</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-11230/16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813828</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CAREWELL 1106/ASPEL ASCARD A4</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-11230/16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813835</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CAREWELL 1112</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-21525/16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813842</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>CAREWELL 1112</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>2026-06-21T14:13:44.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813859</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>COMEN CM100/CM200</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-5020/16R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813866</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>COMEN CM100/CM200</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-5020/16R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813873</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>COMEN CM300</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-8020/13R3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813880</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>COMEN CM300</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-8020/13R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551019813897</udiDi>
    <basicUdiDi>955101981MCRP-APNG</basicUdiDi>
    <tradeName>COROMETRICS AAO 4483</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-CO14045/20R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:13:44.834Z</lastUpdated>
  </row>
</eudamedExport>