<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-71275HB</udiDi>
    <basicUdiDi>B-71275HB</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>Artık piyasada değil</deviceStatus>
    <reference>71275</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:07.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71274H9</udiDi>
    <basicUdiDi>B-71274H9</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>Artık piyasada değil</deviceStatus>
    <reference>71274</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:02.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71265H8</udiDi>
    <basicUdiDi>B-71265H8</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>Piyasada</deviceStatus>
    <reference>71265</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:55.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71264H6</udiDi>
    <basicUdiDi>B-71264H6</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>71264</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:51.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71263H4</udiDi>
    <basicUdiDi>B-71263H4</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>71263</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:50.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71262H2</udiDi>
    <basicUdiDi>B-71262H2</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>71262</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:47.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156001410</udiDi>
    <basicUdiDi>8592156CCRE0057TE</basicUdiDi>
    <tradeName>PDP 50</tradeName>
    <deviceName>PYRIDOXAL-5-PHOSPHATE 50</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10,003,294</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:28:35.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156085601</udiDi>
    <basicUdiDi>8592156CC0RD055NH</basicUdiDi>
    <tradeName>XL URINE DIL</tradeName>
    <deviceName>XL Urine Diluent</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XSYS0067</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:26:49.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>42700037425116</udiDi>
    <basicUdiDi>42700037425CATfluxGN</basicUdiDi>
    <tradeName>CatFlux Solutions</tradeName>
    <deviceName>CatFlux Solutions for the CatSper Test, CatFlux Control and Test Solution</deviceName>
    <manufacturerName>Truion GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000034807</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:33:00.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859882007757</udiDi>
    <basicUdiDi>0859882007Procleix014ZK</basicUdiDi>
    <tradeName>Procleix Parasite Transport Medium</tradeName>
    <deviceName>Procleix Parasite Transport Medium</deviceName>
    <manufacturerName>Grifols Diagnostic Solutions Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004304</manufacturerSrn>
    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001573</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9051577</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:49:42.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859882007610</udiDi>
    <basicUdiDi>0859882007Procleix011ZD</basicUdiDi>
    <tradeName>Procleix Assay Fluids Kit</tradeName>
    <deviceName>Procleix Assay Fluids Kit</deviceName>
    <manufacturerName>Grifols Diagnostic Solutions Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004304</manufacturerSrn>
    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001573</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303344</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:49:37.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859882007405</udiDi>
    <basicUdiDi>0859882007Procleix013ZH</basicUdiDi>
    <tradeName>Procleix SysCheck</tradeName>
    <deviceName>Procleix SysCheck</deviceName>
    <manufacturerName>Grifols Diagnostic Solutions Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004304</manufacturerSrn>
    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001573</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301046E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:49:36.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850032683579</udiDi>
    <basicUdiDi>0859882007Procleix012ZF</basicUdiDi>
    <tradeName>Procleix Auto Detect Reagents</tradeName>
    <deviceName>Procleix Auto Detect Reagents</deviceName>
    <manufacturerName>Grifols Diagnostic Solutions Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004304</manufacturerSrn>
    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001573</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9053575</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:48:30.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852867008053</udiDi>
    <basicUdiDi>0852867008100407DJ</basicUdiDi>
    <tradeName>Oncotype® Sample Prep Kit</tradeName>
    <deviceName>Oncotype Sample Prep Kit</deviceName>
    <manufacturerName>Genomic Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018730</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100422</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:35:57.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768016257</udiDi>
    <basicUdiDi>0405686901045UY</basicUdiDi>
    <tradeName>Dimension Vista V-LYTE Dilution Check</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_V-LYTE Dilution Check</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:48.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768016240</udiDi>
    <basicUdiDi>0405686901044UW</basicUdiDi>
    <tradeName>Dimension Vista V-LYTE Diluent</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_A_REAG_V-LYTE Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:48.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195126000871</udiDi>
    <basicUdiDi>0195126000871QG</basicUdiDi>
    <tradeName>Aptiva System Cleaning Solution Kit</tradeName>
    <deviceName>Aptiva System Cleaning Solution Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC1003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:03:34.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>00192721001241</udiDi>
    <basicUdiDi>0192721U0200400P3</basicUdiDi>
    <tradeName>PGDx elio diversiPhi</tradeName>
    <deviceName>PGDx elio diversiPhi</deviceName>
    <manufacturerName>Personal Genome Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026862</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0840101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:03:18.242Z</lastUpdated>
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  <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-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>
</eudamedExport>