<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987486033776</udiDi>
    <basicUdiDi>4987486BC0107378HB</basicUdiDi>
    <tradeName>HEMOLYSIS WASHING SOLUTION Lite H</tradeName>
    <deviceName>HEMOLYSIS WASHING SOLUTION Lite H</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107378</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:30.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033769</udiDi>
    <basicUdiDi>4987486BC0107377H9</basicUdiDi>
    <tradeName>ADAMS A1c Lite (HA-8380V)</tradeName>
    <deviceName>ADAMS A1c Lite (HA-8380V)</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107377</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:29.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033745</udiDi>
    <basicUdiDi>4987486BC0107375H5</basicUdiDi>
    <tradeName>DILUENT 90</tradeName>
    <deviceName>DILUENT 90</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107375</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:28.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033738</udiDi>
    <basicUdiDi>4987486BC0107374H3</basicUdiDi>
    <tradeName>HEMOLYSIS WASHING SOLUTION 90H</tradeName>
    <deviceName>HEMOLYSIS WASHING SOLUTION 90H</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107374</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:27.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033684</udiDi>
    <basicUdiDi>4987486BC0107369HA</basicUdiDi>
    <tradeName>COLUMN UNIT 90</tradeName>
    <deviceName>COLUMN UNIT 90</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107369</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:26.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033660</udiDi>
    <basicUdiDi>4987486BC0107366H4</basicUdiDi>
    <tradeName>ADAMS A1c (HA-8190V)</tradeName>
    <deviceName>ADAMS A1c (HA-8190V)</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107366</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:26.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033639</udiDi>
    <basicUdiDi>4987486BC0107363GW</basicUdiDi>
    <tradeName>COLUMN UNIT 80T</tradeName>
    <deviceName>COLUMN UNIT 80T</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107363</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:25.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033622</udiDi>
    <basicUdiDi>4987486BC0107361GS</basicUdiDi>
    <tradeName>ADAMS A1c (HA-8180T)</tradeName>
    <deviceName>ADAMS A1c (HA-8180T)</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107361</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:24.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033554</udiDi>
    <basicUdiDi>4987486BC0107350GM</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107350</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:23.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033547</udiDi>
    <basicUdiDi>4987486BC0107349H4</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107349</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:22.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033509</udiDi>
    <basicUdiDi>4987486BC0107345GU</basicUdiDi>
    <tradeName>COLUMN UNIT 80</tradeName>
    <deviceName>COLUMN UNIT 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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107345</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:21.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033486</udiDi>
    <basicUdiDi>4987486BC0107342GN</basicUdiDi>
    <tradeName>ADAMS A1c (HA-8180V)</tradeName>
    <deviceName>ADAMS A1c (HA-8180V)</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107342</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:20.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033370</udiDi>
    <basicUdiDi>4987486BC0107332GK</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName>PocketChem UA (PU-4010)</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107332</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:19.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033134</udiDi>
    <basicUdiDi>4987486BC0107308GN</basicUdiDi>
    <tradeName>AUTION ELEVEN (AE-4020)</tradeName>
    <deviceName>AUTION ELEVEN (AE-4020)</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107308</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:18.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033127</udiDi>
    <basicUdiDi>4987486BC0107295H6</basicUdiDi>
    <tradeName>Washing Solution (Concentrate)</tradeName>
    <deviceName>Washing Solution (Concentrate)</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107295</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:18.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033103</udiDi>
    <basicUdiDi>4987486BC0107293H2</basicUdiDi>
    <tradeName>Concentrated Washing Solution 3</tradeName>
    <deviceName>Concentrated Washing Solution 3</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107293</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:17.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486028659</udiDi>
    <basicUdiDi>4987486BC0105581GU</basicUdiDi>
    <tradeName>The Lab 004 (DB-3910)</tradeName>
    <deviceName>The Lab 004 (DB-3910)</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105581</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:16.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033141</udiDi>
    <basicUdiDi>4987486BC0107308GN</basicUdiDi>
    <tradeName>AUTION ELEVEN (AE-4020)</tradeName>
    <deviceName></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 A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107309</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:21.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033158</udiDi>
    <basicUdiDi>4987486BC0107308GN</basicUdiDi>
    <tradeName>AUTION ELEVEN (AE-4020)</tradeName>
    <deviceName></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 A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107310</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:21.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033387</udiDi>
    <basicUdiDi>4987486BC0107332GK</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName></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 A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107333</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:21.625Z</lastUpdated>
  </row>
</eudamedExport>