<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08680952301268</udiDi>
    <basicUdiDi>8680952301CESR19T</basicUdiDi>
    <tradeName>ESR Control Level 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CESR 1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:23.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301275</udiDi>
    <basicUdiDi>8680952301CESR29V</basicUdiDi>
    <tradeName>ESR Control Level 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CESR 2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:22.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301008</udiDi>
    <basicUdiDi>8680952301ESRGC</basicUdiDi>
    <tradeName>ESR 120 Erythrocyte Sedimentation Rate Analyser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESR 120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:22.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301039</udiDi>
    <basicUdiDi>8680952301ESRGC</basicUdiDi>
    <tradeName>ESR 20 Erythrocyte Sedimentation Rate Analyser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESR 20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:19.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301015</udiDi>
    <basicUdiDi>8680952301ESRGC</basicUdiDi>
    <tradeName>ESR 100 Erythrocyte Sedimentation Rate Analyser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESR 100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:19.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301022</udiDi>
    <basicUdiDi>8680952301ESRGC</basicUdiDi>
    <tradeName>ESR 40 Erythrocyte Sedimentation Rate Analyser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESR 40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:18.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301336</udiDi>
    <basicUdiDi>8680952301ESRGC</basicUdiDi>
    <tradeName>ESR Progress II Erythrocyte Sedimentation Rate Analyser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESR Progress II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:08.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301534</udiDi>
    <basicUdiDi>8680952301ESRGC</basicUdiDi>
    <tradeName>ESR 10 Erythrocyte Sedimentation Rate Analyser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESR 10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:08.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301169</udiDi>
    <basicUdiDi>8680952301Level-1SK</basicUdiDi>
    <tradeName>CP-1 Coagulation Control Plasma Level 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Level-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:07.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301176</udiDi>
    <basicUdiDi>8680952301Level-2SM</basicUdiDi>
    <tradeName>CP-2 Coagulation Control Plasma Level 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Level-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:07.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301091</udiDi>
    <basicUdiDi>8680952301MD-48A</basicUdiDi>
    <tradeName>MD-4 Semi Automated Coagulation Analyser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:07.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301107</udiDi>
    <basicUdiDi>8680952301OPTO-4M7</basicUdiDi>
    <tradeName>OPTO-4 Semi Automated Coagulation Analyser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPTO-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:06.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301084</udiDi>
    <basicUdiDi>8680952301SF-8000BU</basicUdiDi>
    <tradeName>SF-8000 Automated Coagulation Analyser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-8000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:06.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301053</udiDi>
    <basicUdiDi>8680952301TESR16YZD</basicUdiDi>
    <tradeName>ESR Tube 1.6mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESR16Y</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:46:06.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301343</udiDi>
    <basicUdiDi>B-08680952301343</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESRP2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:45:49.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301503</udiDi>
    <basicUdiDi>B-08680952301503</basicUdiDi>
    <tradeName>Cleaning Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCS2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:45:49.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301510</udiDi>
    <basicUdiDi>B-08680952301510</basicUdiDi>
    <tradeName>Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SDIL2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:45:49.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301527</udiDi>
    <basicUdiDi>B-08680952301527</basicUdiDi>
    <tradeName>Progress Control Level 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPCL123</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:45:48.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301299</udiDi>
    <basicUdiDi>B-08680952301299</basicUdiDi>
    <tradeName>Automated Coagulation Analyser Cuvette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>.</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:45:48.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680952301305</udiDi>
    <basicUdiDi>B-08680952301305</basicUdiDi>
    <tradeName>Semi Automated Coagulation Analyser Cuvette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>.</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:45:48.519Z</lastUpdated>
  </row>
</eudamedExport>