<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-109312MR</udiDi>
    <basicUdiDi>B-109312MR</basicUdiDi>
    <tradeName>GLUCOCARD S (GT-7110)</tradeName>
    <deviceName>GLUCOCARD S (GT-7110)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:37.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109311MP</udiDi>
    <basicUdiDi>B-109311MP</basicUdiDi>
    <tradeName>GLUCOCARD S (GT-7110)</tradeName>
    <deviceName>GLUCOCARD S (GT-7110)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:37.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109053MQ</udiDi>
    <basicUdiDi>B-109053MQ</basicUdiDi>
    <tradeName>GLUCOCARD W (GT-7210)</tradeName>
    <deviceName>GLUCOCARD W (GT-7210)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109053</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:52.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109052MN</udiDi>
    <basicUdiDi>B-109052MN</basicUdiDi>
    <tradeName>GLUCOCARD W (GT-7210)</tradeName>
    <deviceName>GLUCOCARD W (GT-7210)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109052</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:50.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109051ML</udiDi>
    <basicUdiDi>B-109051ML</basicUdiDi>
    <tradeName>GLUCOCARD S onyx (GT-7120)</tradeName>
    <deviceName>GLUCOCARD S onyx (GT-7120)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109051</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:48.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109050MJ</udiDi>
    <basicUdiDi>B-109050MJ</basicUdiDi>
    <tradeName>GLUCOCARD S onyx (GT-7120)</tradeName>
    <deviceName>GLUCOCARD S onyx (GT-7120)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109050</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:45.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109049MZ</udiDi>
    <basicUdiDi>B-109049MZ</basicUdiDi>
    <tradeName>GLUCOCARD S (GT-7110)</tradeName>
    <deviceName>GLUCOCARD S (GT-7110)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109049</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:43.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109048MX</udiDi>
    <basicUdiDi>B-109048MX</basicUdiDi>
    <tradeName>GLUCOCARD S (GT-7110)</tradeName>
    <deviceName>GLUCOCARD S (GT-7110)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109048</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:41.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-108480N8</udiDi>
    <basicUdiDi>B-108480N8</basicUdiDi>
    <tradeName>GLUCOCARD S onyx (GT-7120)</tradeName>
    <deviceName>GLUCOCARD S onyx (GT-7120)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>108480</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:37:31.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-108479NP</udiDi>
    <basicUdiDi>B-108479NP</basicUdiDi>
    <tradeName>GLUCOCARD W (GT-7210)</tradeName>
    <deviceName>GLUCOCARD W (GT-7210)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108479</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:37:30.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-108476NH</udiDi>
    <basicUdiDi>B-108476NH</basicUdiDi>
    <tradeName>GLUCOCARD S (GT-7110)</tradeName>
    <deviceName>GLUCOCARD S (GT-7110)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>108476</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:37:24.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105294ML</udiDi>
    <basicUdiDi>B-105294ML</basicUdiDi>
    <tradeName>GLUCOCARD S onyx (GT-7120)</tradeName>
    <deviceName>GLUCOCARD S onyx (GT-7120)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105294</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:22.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-104953N2</udiDi>
    <basicUdiDi>B-104953N2</basicUdiDi>
    <tradeName>GLUCOCARD W (GT-7210)</tradeName>
    <deviceName>GLUCOCARD W (GT-7210)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104953</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:08.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-104861MU</udiDi>
    <basicUdiDi>B-104861MU</basicUdiDi>
    <tradeName>GLUCOCARD S (GT-7110)</tradeName>
    <deviceName>GLUCOCARD S (GT-7110)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104861</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:01.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-104166M3</udiDi>
    <basicUdiDi>B-104166M3</basicUdiDi>
    <tradeName>GLUCOCARD S onyx (GT-7120)</tradeName>
    <deviceName>GLUCOCARD S onyx (GT-7120)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104166</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:26:57.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102023KW</udiDi>
    <basicUdiDi>B-102023KW</basicUdiDi>
    <tradeName>GLUCOCARD SM (GT-7120)</tradeName>
    <deviceName>GLUCOCARD SM (GT-7120)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>102023</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:56:53.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-101953MD</udiDi>
    <basicUdiDi>B-101953MD</basicUdiDi>
    <tradeName>GLUCOCARD S (GT-7110)</tradeName>
    <deviceName>GLUCOCARD S (GT-7110)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101953</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:56:27.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100820LJ</udiDi>
    <basicUdiDi>B-100820LJ</basicUdiDi>
    <tradeName>GLUCOCARD W (GT-7210)</tradeName>
    <deviceName>GLUCOCARD W (GT-7210)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100820</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:37:03.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100819LZ</udiDi>
    <basicUdiDi>B-100819LZ</basicUdiDi>
    <tradeName>GLUCOCARD W (GT-7210)</tradeName>
    <deviceName>GLUCOCARD W (GT-7210)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100819</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:37:01.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100818LX</udiDi>
    <basicUdiDi>B-100818LX</basicUdiDi>
    <tradeName>GLUCOCARD W (GT-7210)</tradeName>
    <deviceName>GLUCOCARD W (GT-7210)</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>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100818</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:37:00.721Z</lastUpdated>
  </row>
</eudamedExport>