<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00811403010356</udiDi>
    <basicUdiDi>081140301CD478700DCL</basicUdiDi>
    <tradeName>Deproteinizer solution</tradeName>
    <deviceName>Deproteinizer Kit</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-478700D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:10.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403010325</udiDi>
    <basicUdiDi>081140301CD104226ADBZ</basicUdiDi>
    <tradeName>Calibrator solution</tradeName>
    <deviceName>348 Wash Pack</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-104226AD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:05.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403010271</udiDi>
    <basicUdiDi>081140301AVBP1025D3F</basicUdiDi>
    <tradeName>Cleaning solution</tradeName>
    <deviceName>ISE Cleaning Solution</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV-BP1025D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:01.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403010189</udiDi>
    <basicUdiDi>081140301AVBP0521D3T</basicUdiDi>
    <tradeName>Deproteinizer solution</tradeName>
    <deviceName>Deproteinizer Solution</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV-BP0521D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:59:55.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403010073</udiDi>
    <basicUdiDi>081140301AVBP0344D3Y</basicUdiDi>
    <tradeName>Diluent solution</tradeName>
    <deviceName>Urine Diluent</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV-BP0344D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:59:39.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000545</udiDi>
    <basicUdiDi>0627595I0900JF</basicUdiDi>
    <tradeName>OMNIgene Liquefaction Reagent</tradeName>
    <deviceName>OMNIgene Liquefaction Reagent</deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-LQR-400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:05:43.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000415</udiDi>
    <basicUdiDi>0627595H0800HX</basicUdiDi>
    <tradeName>PrepIT L2P</tradeName>
    <deviceName>PrepIT L2P</deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT-L2P-5</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:05:38.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-workingsolutioninosXS</udiDi>
    <basicUdiDi>B-workingsolutioninosXS</basicUdiDi>
    <tradeName>Working solution eCMA iNOS</tradeName>
    <deviceName>Working solution eCMA iNOS</deviceName>
    <manufacturerName>Noxygen Science Transfer &amp;  Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-26.1-VIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:31:31.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-spimmXQ</udiDi>
    <basicUdiDi>B-spimmXQ</basicUdiDi>
    <tradeName>Antithrombin III</tradeName>
    <deviceName>Antithrombin III</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0216</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:31:19.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-eCMAMITO6Y</udiDi>
    <basicUdiDi>B-eCMAMITO6Y</basicUdiDi>
    <tradeName>Working solution eCMA MITO</tradeName>
    <deviceName>Working solution eCMA MITO</deviceName>
    <manufacturerName>Noxygen Science Transfer &amp;  Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-22.1-VIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:20.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-eCMAINFLA2A</udiDi>
    <basicUdiDi>B-eCMAINFLA2A</basicUdiDi>
    <tradeName>Arbeitslösung eCMA INFLA</tradeName>
    <deviceName>Working solution eCMA INFLA</deviceName>
    <manufacturerName>Noxygen Science Transfer &amp;  Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-24.1-VIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:20.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-eCMAENDO4H</udiDi>
    <basicUdiDi>B-eCMAENDO4H</basicUdiDi>
    <tradeName>Working solution eCMA ENDO</tradeName>
    <deviceName>Working solution eCMA ENDO</deviceName>
    <manufacturerName>Noxygen Science Transfer &amp;  Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-23.1-VIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:16.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PHAGONOX2RF</udiDi>
    <basicUdiDi>B-PHAGONOX2RF</basicUdiDi>
    <tradeName>Arbeitslösung eCMA PHAGO NOX2</tradeName>
    <deviceName>Working solution PHAGO NOX2</deviceName>
    <manufacturerName>Noxygen Science Transfer &amp;  Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-25.1-VIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:45:04.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Calibrationsolution5G</udiDi>
    <basicUdiDi>B-Calibrationsolution5G</basicUdiDi>
    <tradeName>Calibration solution 3-Carboxy-proxyl</tradeName>
    <deviceName>Calibration solution 3-Carboxy-proxyl</deviceName>
    <manufacturerName>Noxygen Science Transfer &amp;  Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-08.3-VIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:13:46.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMHCY</udiDi>
    <basicUdiDi>B-CMHCY</basicUdiDi>
    <tradeName>CMH</tradeName>
    <deviceName>CMH</deviceName>
    <manufacturerName>Noxygen Science Transfer &amp;  Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-02.5-VIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:08:48.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-31000EN</udiDi>
    <basicUdiDi>B-31000EN</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Coenzyme Q10 in Plasma / Serum</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:17:00.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812512442</udiDi>
    <basicUdiDi>B-08681812512442</basicUdiDi>
    <tradeName>PROTEİN HS</tradeName>
    <deviceName>PROTEIN HIGH SENSITIVE 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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSP21</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:37:47.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812501910</udiDi>
    <basicUdiDi>B-08681812501910</basicUdiDi>
    <tradeName>PROTEİN HS</tradeName>
    <deviceName>PROTEIN HIGH SENSITIVE 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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSP20</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:37:03.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437024427049</udiDi>
    <basicUdiDi>B-08437024427049</basicUdiDi>
    <tradeName>ovoselect</tradeName>
    <deviceName>ovoselect</deviceName>
    <manufacturerName>Halotech DNA</manufacturerName>
    <manufacturerSrn>ES-MF-000001921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-OVS10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:02:11.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437024427032</udiDi>
    <basicUdiDi>B-08437024427032</basicUdiDi>
    <tradeName>oxiSperm II</tradeName>
    <deviceName>oxiSperm II</deviceName>
    <manufacturerName>Halotech DNA</manufacturerName>
    <manufacturerSrn>ES-MF-000001921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-OS20II</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:02:08.296Z</lastUpdated>
  </row>
</eudamedExport>