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<eudamedExport entity="devices">
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    <udiDi>06009710130292</udiDi>
    <basicUdiDi>600971013DBSC5</basicUdiDi>
    <tradeName>Dried Blood Spot Collection Kit, Whatman Cards, without Capillary Tubes, 20 Tests [Lasec]</tradeName>
    <deviceName>Dried Blood Spot Collection Kit, Whatman Cards, with Capillary Tubes, 20 Tests. Single Use</deviceName>
    <manufacturerName>Lasec International (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000040804</manufacturerSrn>
    <authorisedRepresentativeName>TNMC Devices Llc</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HR-AR-000019582</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>KKIT-EXP20TSU-LWP-CB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:48:01.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586747</udiDi>
    <basicUdiDi>5999883586ADTVF</basicUdiDi>
    <tradeName>Atellica DT 250 analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11310504</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:47:18.134Z</lastUpdated>
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  <row>
    <udiDi>05999883586273</udiDi>
    <basicUdiDi>5999883586AJ30QG</basicUdiDi>
    <tradeName>Abacus Junior 30 Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS-1C</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:47:14.127Z</lastUpdated>
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  <row>
    <udiDi>05999883586242</udiDi>
    <basicUdiDi>5999883586A1XN</basicUdiDi>
    <tradeName>Aquila Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1-1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:47:13.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586235</udiDi>
    <basicUdiDi>5999883586A38S9</basicUdiDi>
    <tradeName>Abacus 380 Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A38-1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:47:13.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586204</udiDi>
    <basicUdiDi>5999883586HYPY9</basicUdiDi>
    <tradeName>Diatro•Hypoclean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D7011</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:47:13.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366629</udiDi>
    <basicUdiDi>5999862176BioStainRETAK</basicUdiDi>
    <tradeName>BioStain RET fluorescent reticulocyte 12mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S021</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:42.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862454005</udiDi>
    <basicUdiDi>599986245415L</basicUdiDi>
    <tradeName>Theresa RUO Kit</tradeName>
    <deviceName>Theresa RUO kit</deviceName>
    <manufacturerName>Navolab Diagnosztika Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025337</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK-0001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:41.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366612</udiDi>
    <basicUdiDi>5999862366BioStainNRBCZT</basicUdiDi>
    <tradeName>BioStain NRBC fluorescent NRBC 12mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S024</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:23.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366605</udiDi>
    <basicUdiDi>5999862366BioStainW5PB4</basicUdiDi>
    <tradeName>BioStain W5P fluorescent WBC-5-diff dye 42mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S028</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:22.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366599</udiDi>
    <basicUdiDi>5999862366BioLyseW5PP8</basicUdiDi>
    <tradeName>BioLyse W5P WBC-5-diff lysing reagent 5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L027</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:21.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366582</udiDi>
    <basicUdiDi>5999862366BioLyseNRBC96</basicUdiDi>
    <tradeName>BioLyse NRBC NRBC specific lysing  reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L021</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:20.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366575</udiDi>
    <basicUdiDi>5999862366BioDilRETZA</basicUdiDi>
    <tradeName>BioDil RET reticulocyte buffer 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BioDil RET reticulocyte buffer 1L</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:16.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366551</udiDi>
    <basicUdiDi>5999862366BioDilSWE2A</basicUdiDi>
    <tradeName>BioDil SWE diluent 10L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SW-1115</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:15.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366537</udiDi>
    <basicUdiDi>5999862366BioLyseSWFC</basicUdiDi>
    <tradeName>BioLyse SW WBC-3-diff lysing reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SW-2151</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:15.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366520</udiDi>
    <basicUdiDi>5999862366BioCleanM22QG</basicUdiDi>
    <tradeName>BioClean M22 cleaning reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-5061</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:14.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366506</udiDi>
    <basicUdiDi>5999862366BioLyseM22KK</basicUdiDi>
    <tradeName>BioLyse M22 WBC-5-diff lysing reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-2061</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:10.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366483</udiDi>
    <basicUdiDi>5999862366BioDilM22UR</basicUdiDi>
    <tradeName>BioDil M22 diluent 10L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-1061</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:09.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366469</udiDi>
    <basicUdiDi>5999862366BioCleanNKC8</basicUdiDi>
    <tradeName>BioClean NK cleaning reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W0103010105</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:08.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862366445</udiDi>
    <basicUdiDi>5999862366BioLyseNKE5</basicUdiDi>
    <tradeName>BioLyse NK lysing reagent 0.5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK-2091</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:07.798Z</lastUpdated>
  </row>
</eudamedExport>