<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03610230005101</udiDi>
    <basicUdiDi>B-03610230005101</basicUdiDi>
    <tradeName>ABX Pentra CO2 Cal</tradeName>
    <deviceName>ABX Pentra CO2 Cal</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01648</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:59:26.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004845</udiDi>
    <basicUdiDi>B-03610230004845</basicUdiDi>
    <tradeName>ABX Pentra RF Cal</tradeName>
    <deviceName>ABX Pentra RF Cal</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01618</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:59:02.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111711350</udiDi>
    <basicUdiDi>88001117IPAA01MA02W4</basicUdiDi>
    <tradeName>STANDARD™ M10 Calibration Kit</tradeName>
    <deviceName>STANDARD™ M10 Calibration Kit</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M10-CAL-01/11CAL10H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:19.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111711213</udiDi>
    <basicUdiDi>88001117IPAA01FA29V7</basicUdiDi>
    <tradeName>STANDARD™ F Calibration Kit</tradeName>
    <deviceName>STANDARD™ F Calibration Kit</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CAL10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:17.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699226000103</udiDi>
    <basicUdiDi>86992260CTL3(130)YZ</basicUdiDi>
    <tradeName>CFΔ Collection System</tradeName>
    <deviceName>LINEARISATION SOLUTION 130 (118-142)mmol/L NaCl</deviceName>
    <manufacturerName>UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000016643</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTL3</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:09:10.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699226000073</udiDi>
    <basicUdiDi>86992260CAL90RQ</basicUdiDi>
    <tradeName>CFΔ Collection System</tradeName>
    <deviceName>CALIBRATION SOLUTION 90(88-92) mmol/L NaCl</deviceName>
    <manufacturerName>UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000016643</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL90</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:09:06.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699226000097</udiDi>
    <basicUdiDi>86992260CTL2(70)UP</basicUdiDi>
    <tradeName>CFΔ Collection System</tradeName>
    <deviceName>LINEARISATION SOLUTION  70(64-76) mmol/L NaCl</deviceName>
    <manufacturerName>UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000016643</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTL2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:09:05.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699226000080</udiDi>
    <basicUdiDi>86992260CTL1(40)TV</basicUdiDi>
    <tradeName>CFΔ Collection System</tradeName>
    <deviceName>LINEARISATION SOLUTION 40(35-45) mmol/L NaCl</deviceName>
    <manufacturerName>UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000016643</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTL1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:09:04.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>08430793041126</udiDi>
    <basicUdiDi>843079304112636</basicUdiDi>
    <tradeName>Aptiva® Optical Calibrator Kit</tradeName>
    <deviceName>Aptiva® Optical Calibrator Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC1001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:26:10.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950021766</udiDi>
    <basicUdiDi>84269500217665Q</basicUdiDi>
    <tradeName>ISE High Calibrator</tradeName>
    <deviceName>ISE High Calibrator</deviceName>
    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000009277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0018469300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:02:58.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950021759</udiDi>
    <basicUdiDi>84269500217595T</basicUdiDi>
    <tradeName>ISE Low Calibrator</tradeName>
    <deviceName>ISE Low Calibrator</deviceName>
    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000009277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0018469200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:02:57.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>07791778045074</udiDi>
    <basicUdiDi>7798100041572570KY</basicUdiDi>
    <tradeName>ISE Reagent Module</tradeName>
    <deviceName>ISE Reagent Module</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1572570</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:08:55.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>07791778045067</udiDi>
    <basicUdiDi>7798100041008155GC</basicUdiDi>
    <tradeName>CM Series Reagent Module LT</tradeName>
    <deviceName>CM Series Reagent Module LT</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1008155</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:08:54.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>07791778006686</udiDi>
    <basicUdiDi>7798100041009904HA</basicUdiDi>
    <tradeName>CMD 600 Reagent Module LT</tradeName>
    <deviceName>CMD 600 Reagent Module LT</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1009904</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:08:42.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974235033512</udiDi>
    <basicUdiDi>697423503UMA0002JT</basicUdiDi>
    <tradeName>06974235033512</tradeName>
    <deviceName>MCM Calibrator</deviceName>
    <manufacturerName>Changchun Medicside Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022835</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410202004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:46:18.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974235033499</udiDi>
    <basicUdiDi>697423503UMA0001JR</basicUdiDi>
    <tradeName>06974235033499</tradeName>
    <deviceName>MCM Focus</deviceName>
    <manufacturerName>Changchun Medicside Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022835</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410201003</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:46:17.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974235033376</udiDi>
    <basicUdiDi>697423503UCA0005EX</basicUdiDi>
    <tradeName>06974235033376</tradeName>
    <deviceName>MCC Physical Calibrator</deviceName>
    <manufacturerName>Changchun Medicside Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022835</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410104007</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:46:12.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972873821911</udiDi>
    <basicUdiDi>697287382M-E01M-E02BN</basicUdiDi>
    <tradeName>Calibration Standard Solution</tradeName>
    <deviceName>Calibration Standard Solution</deviceName>
    <manufacturerName>Shenzhen Cornley Bio-Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017322</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>10.40.000111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:19:29.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972873821904</udiDi>
    <basicUdiDi>697287382M-M01JT</basicUdiDi>
    <tradeName>Calibration Standard Solution</tradeName>
    <deviceName>Calibration Standard Solution</deviceName>
    <manufacturerName>Shenzhen Cornley Bio-Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017322</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>10.40.000109</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:19:28.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972873821898</udiDi>
    <basicUdiDi>697287382M-EM1L7</basicUdiDi>
    <tradeName>Calibration Standard Solution</tradeName>
    <deviceName>Calibration Standard Solution</deviceName>
    <manufacturerName>Shenzhen Cornley Bio-Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017322</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>10.40.000065</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:19:24.387Z</lastUpdated>
  </row>
</eudamedExport>