<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-78480JX</udiDi>
    <basicUdiDi>B-78480JX</basicUdiDi>
    <tradeName>GLUCOCARD X-meter CONTROL</tradeName>
    <deviceName>GLUCOCARD X-meter CONTROL</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78480</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:14.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78318JM</udiDi>
    <basicUdiDi>B-78318JM</basicUdiDi>
    <tradeName>GLUCOCARD MX CONTROL</tradeName>
    <deviceName>GLUCOCARD MX CONTROL</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78318</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:12.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78317JK</udiDi>
    <basicUdiDi>B-78317JK</basicUdiDi>
    <tradeName>GLUCOCARD MX CONTROL</tradeName>
    <deviceName>GLUCOCARD MX CONTROL</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78317</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:10.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78315JF</udiDi>
    <basicUdiDi>B-78315JF</basicUdiDi>
    <tradeName>GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS</tradeName>
    <deviceName>GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78315</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:08.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78314JD</udiDi>
    <basicUdiDi>B-78314JD</basicUdiDi>
    <tradeName>GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS</tradeName>
    <deviceName>GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78314</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:07.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78313JB</udiDi>
    <basicUdiDi>B-78313JB</basicUdiDi>
    <tradeName>GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS</tradeName>
    <deviceName>GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78313</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:06.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77743JZ</udiDi>
    <basicUdiDi>B-77743JZ</basicUdiDi>
    <tradeName>GLUCOCARD G sensor</tradeName>
    <deviceName>GLUCOCARD G sensor</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77743</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:23:22.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77742JX</udiDi>
    <basicUdiDi>B-77742JX</basicUdiDi>
    <tradeName>W0101060101</tradeName>
    <deviceName>GLUCOCARD G sensor</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77742</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:23:17.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77741JV</udiDi>
    <basicUdiDi>B-77741JV</basicUdiDi>
    <tradeName>GLUCOCARD G sensor</tradeName>
    <deviceName>GLUCOCARD G sensor</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77741</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:23:16.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77734JY</udiDi>
    <basicUdiDi>B-77734JY</basicUdiDi>
    <tradeName>GLUCOCARD G sensor</tradeName>
    <deviceName>GLUCOCARD G sensor</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77734</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:23:06.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47395HX</udiDi>
    <basicUdiDi>B-47395HX</basicUdiDi>
    <tradeName>GLUCOCARD SM TEST STRIPS</tradeName>
    <deviceName>GLUCOCARD SM TEST STRIPS</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>47395</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:01.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47393HT</udiDi>
    <basicUdiDi>B-47393HT</basicUdiDi>
    <tradeName>GLUCOCARD SM TEST STRIPS</tradeName>
    <deviceName>GLUCOCARD SM TEST STRIPS</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>47393</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:01.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47389J4</udiDi>
    <basicUdiDi>B-47389J4</basicUdiDi>
    <tradeName>GLUCOCARD SM TEST STRIPS</tradeName>
    <deviceName>GLUCOCARD SM TEST STRIPS</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>47389</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:00.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-471987421CSYDLT</udiDi>
    <basicUdiDi>B-471987421CSYDLT</basicUdiDi>
    <tradeName>GDH Glucose control solution</tradeName>
    <deviceName>Glucose control solution (Low, Normal, High)</deviceName>
    <manufacturerName>Leison Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000026417</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:31.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-471987421AP-10STRIPE3SZ</udiDi>
    <basicUdiDi>B-471987421AP-10STRIPE3SZ</basicUdiDi>
    <tradeName>AP-10</tradeName>
    <deviceName>Blood Glucose Test Strip</deviceName>
    <manufacturerName>Leison Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000026417</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:30.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-471987421AP-108W8C</udiDi>
    <basicUdiDi>B-471987421AP-108W8C</basicUdiDi>
    <tradeName>AP-10</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Leison Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000026417</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:26.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487699A08Q</udiDi>
    <basicUdiDi>B-47136487699A08Q</basicUdiDi>
    <tradeName>GlucoSure Star</tradeName>
    <deviceName>GlucoSure Star Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S70304, S70052, S70005, S70008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:12.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487699ATAW</udiDi>
    <basicUdiDi>B-47136487699ATAW</basicUdiDi>
    <tradeName>GlucoSure Star</tradeName>
    <deviceName>GlucoSure Star Blood Glucose Test Strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5636026, S5636046, S5636053, S5636084, S5636094</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:11.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487699ASAU</udiDi>
    <basicUdiDi>B-47136487699ASAU</basicUdiDi>
    <tradeName>Contrex Plus</tradeName>
    <deviceName>Contrex Plus glucose control solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5800012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:10.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487613AUT3C</udiDi>
    <basicUdiDi>B-47136487613AUT3C</basicUdiDi>
    <tradeName>MultiSure</tradeName>
    <deviceName>MultiSure Uric Acid Test Strip</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5640832 S5640833</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:08.787Z</lastUpdated>
  </row>
</eudamedExport>