<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-33699HF</udiDi>
    <basicUdiDi>B-33699HF</basicUdiDi>
    <tradeName>GLUCOCARD G sensor</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 Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>33699</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34103FN</udiDi>
    <basicUdiDi>B-34103FN</basicUdiDi>
    <tradeName>ADAMS A1c (HA-8180)</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34109G2</udiDi>
    <basicUdiDi>B-34109G2</basicUdiDi>
    <tradeName>ADAMS A1c (HA-8180V)</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34109</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34111FM</udiDi>
    <basicUdiDi>B-34111FM</basicUdiDi>
    <tradeName>ADAMS A1c (HA-8180V)</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34114FT</udiDi>
    <basicUdiDi>B-34114FT</basicUdiDi>
    <tradeName>ADAMS A1c (HA-8180T)</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34114</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34116FX</udiDi>
    <basicUdiDi>B-34116FX</basicUdiDi>
    <tradeName>ADAMS A1c (HA-8180T)</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34116</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34847HD</udiDi>
    <basicUdiDi>B-34847HD</basicUdiDi>
    <tradeName>GLUCOCARD G sensor</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 Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>34847</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:51.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-38995JR</udiDi>
    <basicUdiDi>B-38995JR</basicUdiDi>
    <tradeName>GLUCOCARD G sensor</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 Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>38995</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:49.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42508GH</udiDi>
    <basicUdiDi>B-42508GH</basicUdiDi>
    <tradeName>ELUENT 80A</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42508</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:40.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42509GK</udiDi>
    <basicUdiDi>B-42509GK</basicUdiDi>
    <tradeName>ELUENT 80B</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42509</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:40.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42510G4</udiDi>
    <basicUdiDi>B-42510G4</basicUdiDi>
    <tradeName>ELUENT 80CV</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:40.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42511G6</udiDi>
    <basicUdiDi>B-42511G6</basicUdiDi>
    <tradeName>HEMOLYSIS WASHING SOLUTION 80H</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42511</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:40.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42512G8</udiDi>
    <basicUdiDi>B-42512G8</basicUdiDi>
    <tradeName>CONTROL DILUTION SET 80</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>42512</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:40.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42513GA</udiDi>
    <basicUdiDi>B-42513GA</basicUdiDi>
    <tradeName>COLUMN UNIT 80</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42513</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:40.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-46706HK</udiDi>
    <basicUdiDi>B-46706HK</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</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 Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>46706</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:29.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-46707HM</udiDi>
    <basicUdiDi>B-46707HM</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</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 Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>46707</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:29.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-46708HP</udiDi>
    <basicUdiDi>B-46708HP</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</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 Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>46708</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:29.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-46744HT</udiDi>
    <basicUdiDi>B-46744HT</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</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 Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>46744</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:29.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-46745HV</udiDi>
    <basicUdiDi>B-46745HV</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</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 Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>46745</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:29.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-46746HX</udiDi>
    <basicUdiDi>B-46746HX</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</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 Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>46746</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:29.277Z</lastUpdated>
  </row>
</eudamedExport>