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<eudamedExport entity="devices">
  <row>
    <udiDi>06945040106913</udiDi>
    <basicUdiDi>69450401CMS1700DT</basicUdiDi>
    <tradeName>Color Doppler Ultrasound Diagnostic System</tradeName>
    <deviceName>Color Doppler 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>Z11040105</emdnCode>
    <emdnDescription>OBSTETRIC/GYNAECOLOGICAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS1700C</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:47.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106753</udiDi>
    <basicUdiDi>69450401SC11N4</basicUdiDi>
    <tradeName>Stethoscope</tradeName>
    <deviceName>Stethoscope</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>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC23</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:46.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106715</udiDi>
    <basicUdiDi>69450401CMS-GS1JJ</basicUdiDi>
    <tradeName>Video Laryngoscope</tradeName>
    <deviceName>Video Laryngoscope</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>Z12021004</emdnCode>
    <emdnDescription>VIDEO LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS-GS1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:40.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106593</udiDi>
    <basicUdiDi>69450401CMS1700DT</basicUdiDi>
    <tradeName>Color Doppler Ultrasound Diagnostic System</tradeName>
    <deviceName>Color Doppler 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>Z11040105</emdnCode>
    <emdnDescription>OBSTETRIC/GYNAECOLOGICAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS1700B</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:40.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106432</udiDi>
    <basicUdiDi>69450401SP70BLZ</basicUdiDi>
    <tradeName>SPIROMETER</tradeName>
    <deviceName>SPIROMETER</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>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP80B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:38.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106265</udiDi>
    <basicUdiDi>69450401SC11N4</basicUdiDi>
    <tradeName>Stethoscope</tradeName>
    <deviceName>Stethoscope</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>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:37.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106159</udiDi>
    <basicUdiDi>69450401SC11N4</basicUdiDi>
    <tradeName>Stethoscope</tradeName>
    <deviceName>Stethoscope</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>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC21</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:29.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106142</udiDi>
    <basicUdiDi>69450401SC11N4</basicUdiDi>
    <tradeName>Stethoscope</tradeName>
    <deviceName>Stethoscope</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>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC12</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:28.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106135</udiDi>
    <basicUdiDi>69450401SC11N4</basicUdiDi>
    <tradeName>Stethoscope</tradeName>
    <deviceName>Stethoscope</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>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC11</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:27.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105930</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>IGN0009</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:26.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105923</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>IGN0057</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:20.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105756</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>ECG1212G</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:19.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105565</udiDi>
    <basicUdiDi>69450401CONTEC21WV</basicUdiDi>
    <tradeName>Oxygen Concentrator</tradeName>
    <deviceName>Oxygen Concentrator</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>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONTEC21</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:18.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105558</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-M01L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:15.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105411</udiDi>
    <basicUdiDi>69450401CONTEC10CA7</basicUdiDi>
    <tradeName>Pocket Fetal Doppler</tradeName>
    <deviceName>Pocket Fetal Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONTEC10CL</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:09.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105404</udiDi>
    <basicUdiDi>69450401CONTEC10CA7</basicUdiDi>
    <tradeName>Pocket Fetal Doppler</tradeName>
    <deviceName>Pocket Fetal Doppler</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>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONTEC10C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:08.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105220</udiDi>
    <basicUdiDi>69450401CONTEC07AAK</basicUdiDi>
    <tradeName>Electronic Sphygmomanometer</tradeName>
    <deviceName>Electronic Sphygmomanometer</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>Z1203020302</emdnCode>
    <emdnDescription>NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONTEC07A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:07.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105138</udiDi>
    <basicUdiDi>69450401TP500KY</basicUdiDi>
    <tradeName>Infrared Thermometer</tradeName>
    <deviceName>Infrared Thermometer</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>V0301010202</emdnCode>
    <emdnDescription>NON-CONTACT DIGITAL THERMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TP500</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:19:05.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040104681</udiDi>
    <basicUdiDi>69450401CA10MBY</basicUdiDi>
    <tradeName>Capnograph</tradeName>
    <deviceName>Capnograph</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>Z1203020401</emdnCode>
    <emdnDescription>CARBON DIOXIDE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA10M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:59.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040104421</udiDi>
    <basicUdiDi>69450401PM10NX</basicUdiDi>
    <tradeName>Portable ECG Monitor</tradeName>
    <deviceName>Portable ECG Monitor</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>PM10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:18:57.450Z</lastUpdated>
  </row>
</eudamedExport>