<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>G4583210016J</udiDi>
    <basicUdiDi>B-G4583210016J</basicUdiDi>
    <tradeName>Urea/BUN - LS (Modified Urease-Berthlot Method)</tradeName>
    <deviceName>Urea/BUN - LS (Modified Urease-Berthlot Method)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>321 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:37:19.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>G4583200045J</udiDi>
    <basicUdiDi>B-G4583200045J</basicUdiDi>
    <tradeName>Urea/BUN - single reagent</tradeName>
    <deviceName>Urea/BUN - single reagent</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>320 004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:37:18.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>G4583200033J</udiDi>
    <basicUdiDi>B-G4583200033J</basicUdiDi>
    <tradeName>Urea/BUN - single reagent</tradeName>
    <deviceName>Urea/BUN - single reagent</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>320 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:37:17.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458320002ZH</udiDi>
    <basicUdiDi>B-G458320002ZH</basicUdiDi>
    <tradeName>Urea/BUN - single reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>320 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:37.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458320001XH</udiDi>
    <basicUdiDi>B-G458320001XH</basicUdiDi>
    <tradeName>Urea/BUN - single reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>320 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:36.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>G4583190055M</udiDi>
    <basicUdiDi>B-G4583190055M</basicUdiDi>
    <tradeName>Urea/BUN - Liquizyme (UV)</tradeName>
    <deviceName>Urea/BUN - Liquizyme (UV)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>319 005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:35.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>G4583190043M</udiDi>
    <basicUdiDi>B-G4583190043M</basicUdiDi>
    <tradeName>Urea/BUN - Liquizyme (UV)</tradeName>
    <deviceName>Urea/BUN - Liquizyme (UV)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>319 004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:34.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458319003ZL</udiDi>
    <basicUdiDi>B-G458319003ZL</basicUdiDi>
    <tradeName>Urea/BUN - Liquizyme (UV)</tradeName>
    <deviceName>Urea/BUN - Liquizyme (UV)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>319 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:34.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458319002XL</udiDi>
    <basicUdiDi>B-G458319002XL</basicUdiDi>
    <tradeName>Urea/BUN - Liquizyme (UV)</tradeName>
    <deviceName>Urea/BUN - Liquizyme (UV)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>319 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:33.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458319001VL</udiDi>
    <basicUdiDi>B-G458319001VL</basicUdiDi>
    <tradeName>Urea/BUN - Liquizyme (UV)</tradeName>
    <deviceName>Urea/BUN - Liquizyme (UV)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>319 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:29.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458318002XL</udiDi>
    <basicUdiDi>B-G458318002XL</basicUdiDi>
    <tradeName>Urea/BUN - (Modified Urease - Berthlot Method)</tradeName>
    <deviceName>Urea/BUN - (Modified Urease - Berthlot Method)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>318 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:28.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>G4583180043M</udiDi>
    <basicUdiDi>B-G4583180043M</basicUdiDi>
    <tradeName>Urea/BUN - (Modified Urease - Berthlot Method)</tradeName>
    <deviceName>Urea/BUN - (Modified Urease - Berthlot Method)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>318 004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:27.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458318003ZL</udiDi>
    <basicUdiDi>B-G458318003ZL</basicUdiDi>
    <tradeName>Urea/BUN - (Modified Urease - Berthlot Method)</tradeName>
    <deviceName>Urea/BUN - (Modified Urease - Berthlot Method)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>318 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:26.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458318001VL</udiDi>
    <basicUdiDi>B-G458318001VL</basicUdiDi>
    <tradeName>Urea/BUN - (Modified Urease - Berthlot Method)</tradeName>
    <deviceName>Urea/BUN - (Modified Urease - Berthlot Method)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>318 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:26.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>G4582810018N</udiDi>
    <basicUdiDi>B-G4582810018N</basicUdiDi>
    <tradeName>Lipase w. Calibrator</tradeName>
    <deviceName>Lipase w. Calibrator</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>281 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:20.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458279002CR</udiDi>
    <basicUdiDi>B-G458279002CR</basicUdiDi>
    <tradeName>Lactate dehydrogenase (LDH) - Liquizyme (1+1)</tradeName>
    <deviceName>Lactate dehydrogenase (LDH) - Liquizyme</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010120</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE P ( LDH - P --&gt; L )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>279 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:19.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458279001AR</udiDi>
    <basicUdiDi>B-G458279001AR</basicUdiDi>
    <tradeName>Lactate dehydrogenase (LDH) - Liquizyme (1+1)</tradeName>
    <deviceName>Lactate dehydrogenase (LDH) - Liquizyme (1+1)</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010120</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE P ( LDH - P --&gt; L )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>279 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:19.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458239004CM</udiDi>
    <basicUdiDi>B-G458239004CM</basicUdiDi>
    <tradeName>Creatine Kinase MB</tradeName>
    <deviceName>Creatine Kinase MB</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>239 004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:18.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>G458239003AM</udiDi>
    <basicUdiDi>B-G458239003AM</basicUdiDi>
    <tradeName>Creatine Kinase MB</tradeName>
    <deviceName>Creatine Kinase MB</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>239 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:14.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>G4582390028M</udiDi>
    <basicUdiDi>B-G4582390028M</basicUdiDi>
    <tradeName>Creatine Kinase MB</tradeName>
    <deviceName>Creatine Kinase MB</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>239 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:34:13.506Z</lastUpdated>
  </row>
</eudamedExport>