<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>16935784410015</udiDi>
    <basicUdiDi>B-16935784410015</basicUdiDi>
    <tradeName>16935784410015</tradeName>
    <deviceName>Glycohemoglobin Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-M22</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:58.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935784410008</udiDi>
    <basicUdiDi>B-16935784410008</basicUdiDi>
    <tradeName>16935784410008</tradeName>
    <deviceName>Glycohemoglobin Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-M21</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:57.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189283432</udiDi>
    <basicUdiDi>B-14560189283432</basicUdiDi>
    <tradeName>14560189283432</tradeName>
    <deviceName>G7 HSi Elution Buffer No.3 (S)</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0019546</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:04:07.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189283425</udiDi>
    <basicUdiDi>B-14560189283425</basicUdiDi>
    <tradeName>14560189283425</tradeName>
    <deviceName>G7 HSi Elution Buffer No.2 (S)</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0019545</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:04:06.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189283418</udiDi>
    <basicUdiDi>B-14560189283418</basicUdiDi>
    <tradeName>14560189283418</tradeName>
    <deviceName>G7 HSi Elution Buffer No.1 (S)</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0019544</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:04:02.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109512N3</udiDi>
    <basicUdiDi>B-109512N3</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>109512</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:46:28.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109324MY</udiDi>
    <basicUdiDi>B-109324MY</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>109324</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:53.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109323MW</udiDi>
    <basicUdiDi>B-109323MW</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>109323</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:53.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109316MZ</udiDi>
    <basicUdiDi>B-109316MZ</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>109316</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:45.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109315MX</udiDi>
    <basicUdiDi>B-109315MX</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>109315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:45.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109314MV</udiDi>
    <basicUdiDi>B-109314MV</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>109314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:39.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109313MT</udiDi>
    <basicUdiDi>B-109313MT</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>109313</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:38.712Z</lastUpdated>
  </row>
  <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>
</eudamedExport>