<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-ESRKrebsHEPESPufferD5</udiDi>
    <basicUdiDi>B-ESRKrebsHEPESPufferD5</basicUdiDi>
    <tradeName>ESR-Krebs HEPES Buffer VIT</tradeName>
    <deviceName>ESR-Krebs HEPES Buffer VIT</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-21.2-VIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:02:45.380Z</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-47301GU</udiDi>
    <basicUdiDi>B-47301GU</basicUdiDi>
    <tradeName>ELUENT 80CT</tradeName>
    <deviceName>ELUENT 80CT</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:02:00.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-472055PX</udiDi>
    <basicUdiDi>B-472055PX</basicUdiDi>
    <tradeName>PVT5 (Precision and Accuracy Check)</tradeName>
    <deviceName>PVT5 (Precision and Accuracy Check)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472055</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:39.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-442831PQ</udiDi>
    <basicUdiDi>B-442831PQ</basicUdiDi>
    <tradeName>PVT2 (Buffer Blank And Cuvette Dryness Test)</tradeName>
    <deviceName>PVT2 (Buffer Blank And Cuvette Dryness Test)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442831</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:17.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-442830PN</udiDi>
    <basicUdiDi>B-442830PN</basicUdiDi>
    <tradeName>PVT3 (Combined Carryover Test)</tradeName>
    <deviceName>PVT3 (Combined Carryover Test)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442830</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:15.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>42625753901396</udiDi>
    <basicUdiDi>B-42625753901396</basicUdiDi>
    <tradeName>Z-Hb Confirm Reagent Kit (HPLC)</tradeName>
    <deviceName>Z-Hb Confirm Reagent Kit (HPLC)</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RHB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:32.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>42625753900238</udiDi>
    <basicUdiDi>B-42625753900238</basicUdiDi>
    <tradeName>Daily Cleaners kit</tradeName>
    <deviceName>Daily Cleaners kit</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZA-EC1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:19.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42512G8</udiDi>
    <basicUdiDi>B-42512G8</basicUdiDi>
    <tradeName>CONTROL DILUTION SET 80</tradeName>
    <deviceName>CONTROL DILUTION SET 80</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>42512</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:18.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42511G6</udiDi>
    <basicUdiDi>B-42511G6</basicUdiDi>
    <tradeName>HEMOLYSIS WASHING SOLUTION 80H</tradeName>
    <deviceName>HEMOLYSIS WASHING SOLUTION 80H</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42511</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:18.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42510G4</udiDi>
    <basicUdiDi>B-42510G4</basicUdiDi>
    <tradeName>ELUENT 80CV</tradeName>
    <deviceName>ELUENT 80CV</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42510</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:17.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42508GH</udiDi>
    <basicUdiDi>B-42508GH</basicUdiDi>
    <tradeName>ELUENT 80A</tradeName>
    <deviceName>ELUENT 80A</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42508</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:13.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42509GK</udiDi>
    <basicUdiDi>B-42509GK</basicUdiDi>
    <tradeName>ELUENT 80B</tradeName>
    <deviceName>ELUENT 80B</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42509</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:10.968Z</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>06925912735489</udiDi>
    <basicUdiDi>692591270287HZ</basicUdiDi>
    <tradeName>06925912735489</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC9002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.307Z</lastUpdated>
  </row>
</eudamedExport>