<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987486051367</udiDi>
    <basicUdiDi>4987486BC0110048FD</basicUdiDi>
    <tradeName>SpotChem EL 2 (SE-1530)</tradeName>
    <deviceName>SpotChem EL 2 (SE-1530)</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>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111113</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:04:01.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486047216</udiDi>
    <basicUdiDi>4987486BC0110046F9</basicUdiDi>
    <tradeName>SpotChem D-Concept 2e (SD-4840)</tradeName>
    <deviceName>SpotChem D-Concept 2e (SD-4840)</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 (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110046</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:04:00.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486043768</udiDi>
    <basicUdiDi>4987486BC0109274HC</basicUdiDi>
    <tradeName>Hemolysis Solution</tradeName>
    <deviceName>Hemolysis Solution</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>109274</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:59.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486039594</udiDi>
    <basicUdiDi>4987486BC0108412GR</basicUdiDi>
    <tradeName>AutionIDaten (AE-4070)</tradeName>
    <deviceName>AutionIDaten (AE-4070)</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>108412</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:59.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486047186</udiDi>
    <basicUdiDi>4987486BC0110044F5</basicUdiDi>
    <tradeName>SpotChem D-Concept 2c (SD-4830)</tradeName>
    <deviceName>SpotChem D-Concept 2c (SD-4830)</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>110044</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:57.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486044604</udiDi>
    <basicUdiDi>4987486BC0109504H6</basicUdiDi>
    <tradeName>WeCheck for S onyx</tradeName>
    <deviceName>WeCheck for S onyx</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 DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109504</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:56.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486039129</udiDi>
    <basicUdiDi>4987486BC0108243GS</basicUdiDi>
    <tradeName>Centrifuge Tube (for SPOTCHEM EZ)</tradeName>
    <deviceName>Centrifuge Tube (for SPOTCHEM EZ)</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>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108243</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:42.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486039105</udiDi>
    <basicUdiDi>4987486BC0108241GN</basicUdiDi>
    <tradeName>Whole Blood Sample Tube</tradeName>
    <deviceName>Whole Blood Sample Tube</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>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108241</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:42.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486039099</udiDi>
    <basicUdiDi>4987486BC0108240GL</basicUdiDi>
    <tradeName>Centrifuge Cup (for D-Concept)</tradeName>
    <deviceName>Centrifuge Cup (for D-Concept)</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>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:41.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486037361</udiDi>
    <basicUdiDi>4987486BC0107856HS</basicUdiDi>
    <tradeName>PocketChem Printer</tradeName>
    <deviceName>PocketChem Printer</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>W02079080</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107856</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:40.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486039075</udiDi>
    <basicUdiDi>4987486BC0108238GZ</basicUdiDi>
    <tradeName>Cuvette (heparin)</tradeName>
    <deviceName>Cuvette (heparin)</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>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108238</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:39.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486039044</udiDi>
    <basicUdiDi>4987486BC0108223GL</basicUdiDi>
    <tradeName>The Lab 001 (CE-8810)</tradeName>
    <deviceName>The Lab 001 (CE-8810)</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>CAPILLARY ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108223</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:38.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486038009</udiDi>
    <basicUdiDi>4987486BC0107975J3</basicUdiDi>
    <tradeName>SPOTCHEM EL (SE-1520)</tradeName>
    <deviceName>SPOTCHEM EL (SE-1520)</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>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107975</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:37.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486036227</udiDi>
    <basicUdiDi>4987486BC0107687HT</basicUdiDi>
    <tradeName>PocketChem BA (PA-4140)</tradeName>
    <deviceName>PocketChem BA (PA-4140)</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>BLOOD-AMMONIA CHECKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107687</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:35.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486035985</udiDi>
    <basicUdiDi>4987486BC0107664HF</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName>AUTION EYE Sheath Solution</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>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107664</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:34.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486034605</udiDi>
    <basicUdiDi>4987486BC0107507GW</basicUdiDi>
    <tradeName>SPOTCHEM D-00 QR (SD-9811)</tradeName>
    <deviceName>SPOTCHEM D-00 QR (SD-9811)</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>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107507</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:34.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486034582</udiDi>
    <basicUdiDi>4987486BC0107505GS</basicUdiDi>
    <tradeName>SPOTCHEM D-03 (SD-4820)</tradeName>
    <deviceName>SPOTCHEM D-03 (SD-4820)</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>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107505</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:33.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486034575</udiDi>
    <basicUdiDi>4987486BC0107504GQ</basicUdiDi>
    <tradeName>SPOTCHEM D-02 (SD-4810)</tradeName>
    <deviceName>SPOTCHEM D-02 (SD-4810)</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>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107504</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:32.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486034568</udiDi>
    <basicUdiDi>4987486BC0107503GN</basicUdiDi>
    <tradeName>SPOTCHEM D-01 (SD-3810)</tradeName>
    <deviceName>SPOTCHEM D-01 (SD-3810)</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>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107503</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:31.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486034551</udiDi>
    <basicUdiDi>4987486BC0107501GJ</basicUdiDi>
    <tradeName>SPOTCHEM EZ (SP-4430)</tradeName>
    <deviceName>SPOTCHEM EZ (SP-4430)</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>107501</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:30.891Z</lastUpdated>
  </row>
</eudamedExport>