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<eudamedExport entity="devices">
  <row>
    <udiDi>D-107839NQ</udiDi>
    <basicUdiDi>B-107839NQ</basicUdiDi>
    <tradeName>The Lab 004 Urea/BUN</tradeName>
    <deviceName>The Lab 004 Urea/BUN</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107839</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:18:01.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037900876</udiDi>
    <basicUdiDi>B-08800037900876</basicUdiDi>
    <tradeName>08800037900876</tradeName>
    <deviceName>SimplexTAS 101 BUN Reagent Cartridge</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0101008</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:06:08.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555613837</udiDi>
    <basicUdiDi>B-08683555613837</basicUdiDi>
    <tradeName>UREA-S Kit</tradeName>
    <deviceName>UREA-S Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B24290</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:34:51.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555612274</udiDi>
    <basicUdiDi>B-08683555612274</basicUdiDi>
    <tradeName>Urea-S</tradeName>
    <deviceName>Urea-S</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B22290</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:30:32.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555611031</udiDi>
    <basicUdiDi>B-08683555611031</basicUdiDi>
    <tradeName>Uric Acid Kit</tradeName>
    <deviceName>Uric Acid</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21295</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:27:36.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555611017</udiDi>
    <basicUdiDi>B-08683555611017</basicUdiDi>
    <tradeName>Urea S 426 mL</tradeName>
    <deviceName>UREA-S</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21290</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:27:34.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555611024</udiDi>
    <basicUdiDi>B-08683555611024</basicUdiDi>
    <tradeName>Urea-S</tradeName>
    <deviceName>Urea-S</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21291</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:27:34.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555601933</udiDi>
    <basicUdiDi>B-08683555601933</basicUdiDi>
    <tradeName>UREA Kit</tradeName>
    <deviceName>UREA Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B28291</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:24:06.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156080965</udiDi>
    <basicUdiDi>8592156CCRE0019T6</basicUdiDi>
    <tradeName>UREA 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLT00060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:50.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156080972</udiDi>
    <basicUdiDi>8592156CCRE0019T6</basicUdiDi>
    <tradeName>UREA 250</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLT00061</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:49.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526081</udiDi>
    <basicUdiDi>B-08681812526081</basicUdiDi>
    <tradeName>ÜRE KİTİ</tradeName>
    <deviceName>UREA REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06T81-62</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:40:13.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526074</udiDi>
    <basicUdiDi>B-08681812526074</basicUdiDi>
    <tradeName>UREA REAGENT</tradeName>
    <deviceName>UREA REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06T81-61</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:40:12.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812525497</udiDi>
    <basicUdiDi>B-08681812525497</basicUdiDi>
    <tradeName>ÜRE</tradeName>
    <deviceName>UREA REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T2233</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:39:51.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812525480</udiDi>
    <basicUdiDi>B-08681812525480</basicUdiDi>
    <tradeName>ÜRE</tradeName>
    <deviceName>UREA REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T2232</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:39:47.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360387687686LB</udiDi>
    <basicUdiDi>B-084360387687686LB</basicUdiDi>
    <tradeName>Urea liquid, R1 4 x 50 mL, R2 1 x 50 mL</tradeName>
    <deviceName>Urea liquid, R1 4 x 50 mL, R2 1 x 50 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0575</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:32:16.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360386326320EV</udiDi>
    <basicUdiDi>B-084360386326320EV</basicUdiDi>
    <tradeName>Urea Berthelot, 2 x 100 mL</tradeName>
    <deviceName>Urea Berthelot, 2 x 100 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0425</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:56.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385985982L9</udiDi>
    <basicUdiDi>B-084360385985982L9</basicUdiDi>
    <tradeName>Urea UV, 5 x 20 mL</tradeName>
    <deviceName>Urea UV, 5 x 20 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0294</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:15.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385915913H9</udiDi>
    <basicUdiDi>B-084360385915913H9</basicUdiDi>
    <tradeName>Urea UV, 4 x 50 mL</tradeName>
    <deviceName>Urea UV, 4 x 50 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0274</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:08.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385805800G3</udiDi>
    <basicUdiDi>B-084360385805800G3</basicUdiDi>
    <tradeName>Urea Berthelot, 4 x 250 mL</tradeName>
    <deviceName>Urea Berthelot, 4 x 250 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0248</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:55.935Z</lastUpdated>
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  <row>
    <udiDi>08435287115376</udiDi>
    <basicUdiDi>B-08435287115376</basicUdiDi>
    <tradeName>08435287115376</tradeName>
    <deviceName>UREA/BUN - COLOR</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:47:03.111Z</lastUpdated>
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</eudamedExport>