<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06945040103462</udiDi>
    <basicUdiDi>69450401ECG1212G5V</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECG90A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:56.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040103455</udiDi>
    <basicUdiDi>69450401CONTEC8000GA5</basicUdiDi>
    <tradeName>ECG Workstation</tradeName>
    <deviceName>ECG Workstation</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONTEC8000G</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:55.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040103363</udiDi>
    <basicUdiDi>69450401BC400AS</basicUdiDi>
    <tradeName>Urine Analyzer</tradeName>
    <deviceName>Urine Analyzer</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:49.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040103356</udiDi>
    <basicUdiDi>69450401BC300AM</basicUdiDi>
    <tradeName>Semi-auto Biochemistry Analyzer</tradeName>
    <deviceName>Semi-auto Biochemistry Analyzer</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC300</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:48.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040103349</udiDi>
    <basicUdiDi>69450401NE-M01BK</basicUdiDi>
    <tradeName>Mesh Nebulizer</tradeName>
    <deviceName>Mesh Nebulizer</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040210</emdnCode>
    <emdnDescription>ULTRASONIC NEBULISERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-M01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:46.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040103332</udiDi>
    <basicUdiDi>69450401SP750LE</basicUdiDi>
    <tradeName>Infusion Pump</tradeName>
    <deviceName>Infusion Pump</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030301</emdnCode>
    <emdnDescription>INFUSION PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP750</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:44.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101680</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName>NIBP Cuff</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0006</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:38.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101673</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName>NIBP Cuff</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:37.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101666</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName>NIBP Cuff</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0004</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:35.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101406</udiDi>
    <basicUdiDi>69450401TLC6000GX</basicUdiDi>
    <tradeName>Dynamic ECG Systems</tradeName>
    <deviceName>Dynamic ECG Systems</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLC6000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:34.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101369</udiDi>
    <basicUdiDi>69450401BC401AU</basicUdiDi>
    <tradeName>Urine analyzer</tradeName>
    <deviceName>Urine Analyzer</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:27.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101338</udiDi>
    <basicUdiDi>69450401ESA0008AB</basicUdiDi>
    <tradeName>Pulse Oximeter Probe</tradeName>
    <deviceName>Pulse Oximeter Probe</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESA0008</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:26.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101246</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName>NIBP Cuff</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:25.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101239</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName>NIBP Cuff</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:22.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101222</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName>NIBP Cuff</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0040</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:15.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101215</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName>NIBP Cuff</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0003</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:14.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101208</udiDi>
    <basicUdiDi>69450401IGNYH</basicUdiDi>
    <tradeName>NIBP Cuff</tradeName>
    <deviceName>NIBP Cuff</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGN0050</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:13.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101161</udiDi>
    <basicUdiDi>69450401CMS600P2HG</basicUdiDi>
    <tradeName>B-Ultrasound Diagnostic System</tradeName>
    <deviceName>B-Ultrasound Diagnostic System</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS600P2</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:11.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040101154</udiDi>
    <basicUdiDi>69450401RS01QA</basicUdiDi>
    <tradeName>Sleep apnea screen meter</tradeName>
    <deviceName>Sleep apnea screen meter</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030299</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:05.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040100799</udiDi>
    <basicUdiDi>69450401CMS50DFG</basicUdiDi>
    <tradeName>pulse  oximeter</tradeName>
    <deviceName>Pulse Oximeter</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020408</emdnCode>
    <emdnDescription>PULSE OXIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS50DL</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:04.626Z</lastUpdated>
  </row>
</eudamedExport>