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<eudamedExport entity="devices">
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    <tradeName>deltaPREP Blood DNA Kit – PP Mini (MDX) Plate 96 rxn</tradeName>
    <deviceName>deltaPREP Blood DNA Kit – PP Mini (MDX)</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024606</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>31-DP-6000096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:14:58.671Z</lastUpdated>
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  <row>
    <udiDi>04262375224016</udiDi>
    <basicUdiDi>4262375220048P</basicUdiDi>
    <tradeName>deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX) (96 rxn)</tradeName>
    <deviceName>deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX)</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024606</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>31-DP-2000096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:14:53.866Z</lastUpdated>
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  <row>
    <udiDi>04262375223019</udiDi>
    <basicUdiDi>4262375220038M</basicUdiDi>
    <tradeName>deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn)</tradeName>
    <deviceName>deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16rxn) Stripes</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024606</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>31-DP-5010016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:14:53.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262375222012</udiDi>
    <basicUdiDi>4262375220028K</basicUdiDi>
    <tradeName>deltaPREP Blood DNA Mini Kit – IPC16 (MDX)</tradeName>
    <deviceName>deltaPREP Blood DNA Mini Kit – IPC16 (MDX)</deviceName>
    <manufacturerName>IST Innuscreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024606</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>31-DP-5000016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:14:52.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005552</udiDi>
    <basicUdiDi>361023pentra_clean_chemHQ</basicUdiDi>
    <tradeName>ABX Pentra Clean-Chem 99 CP</tradeName>
    <deviceName>ABX Pentra Clean-Chem CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</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>A11A01789</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:50.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005514</udiDi>
    <basicUdiDi>361023pentra_etchingNN</basicUdiDi>
    <tradeName>ABX Pentra Etching CP</tradeName>
    <deviceName>ABX Pentra Etching CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</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>A11A01769</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:12.061Z</lastUpdated>
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  <row>
    <udiDi>03610230005491</udiDi>
    <basicUdiDi>361023pentra_clean_chemHQ</basicUdiDi>
    <tradeName>ABX Pentra Clean-Chem CP</tradeName>
    <deviceName>ABX Pentra Clean-Chem CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</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>A11A01755</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:07.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005484</udiDi>
    <basicUdiDi>361023pentra_deprotHD</basicUdiDi>
    <tradeName>ABX Pentra Deproteinizer CP</tradeName>
    <deviceName>ABX Pentra Deproteinizer CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</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>A11A01754</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:06.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231903</udiDi>
    <basicUdiDi>150995901447420KX</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems BUF 4 Buffer 4</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems BUF 4 Buffer 4</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</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>447420</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:13.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590231712</udiDi>
    <basicUdiDi>150995901447060KP</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems Wash Solution</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems Wash Solution</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</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>447060</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:12.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590226961</udiDi>
    <basicUdiDi>150995901447050KL</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems BUF 3 Buffer 3</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems BUF 3 Buffer 3</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</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>447050</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:00.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987486044212</udiDi>
    <basicUdiDi>4987486BC0109340GY</basicUdiDi>
    <tradeName>ELUENT C</tradeName>
    <deviceName>ELUENT C</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>109340</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:40:12.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987486044205</udiDi>
    <basicUdiDi>4987486BC0109339HF</basicUdiDi>
    <tradeName>ELUENT B</tradeName>
    <deviceName>ELUENT B</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>109339</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:40:11.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987486044199</udiDi>
    <basicUdiDi>4987486BC0109338HD</basicUdiDi>
    <tradeName>ELUENT A</tradeName>
    <deviceName>ELUENT A</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>109338</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:39:56.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71292HB</udiDi>
    <basicUdiDi>B-71292HB</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>Artık piyasada değil</deviceStatus>
    <reference>71292</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:25.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71291H9</udiDi>
    <basicUdiDi>B-71291H9</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>71291</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:22.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71279HK</udiDi>
    <basicUdiDi>B-71279HK</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>Artık piyasada değil</deviceStatus>
    <reference>71279</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:14.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71278HH</udiDi>
    <basicUdiDi>B-71278HH</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>71278</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:12.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71277HF</udiDi>
    <basicUdiDi>B-71277HF</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>71277</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:11.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-71276HD</udiDi>
    <basicUdiDi>B-71276HD</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>71276</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:09.344Z</lastUpdated>
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</eudamedExport>