<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-780609981T6</udiDi>
    <basicUdiDi>B-780609981T6</basicUdiDi>
    <tradeName>BM Test HbA1c Calibrator</tradeName>
    <deviceName>BM Test HbA1c Calibrator</deviceName>
    <manufacturerName>JEOL Ltd. MF</manufacturerName>
    <manufacturerSrn>JP-MF-000026608</manufacturerSrn>
    <authorisedRepresentativeName>JEOL(Europe)BV AR</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023086</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>780609981</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:34.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-780609972T5</udiDi>
    <basicUdiDi>B-780609972T5</basicUdiDi>
    <tradeName>BM Test HbA1c Reagent 2</tradeName>
    <deviceName>BM Test HbA1c Reagent 2</deviceName>
    <manufacturerName>JEOL Ltd. MF</manufacturerName>
    <manufacturerSrn>JP-MF-000026608</manufacturerSrn>
    <authorisedRepresentativeName>JEOL(Europe)BV AR</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023086</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>780609972</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:29.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-780609956T7</udiDi>
    <basicUdiDi>B-780609956T7</basicUdiDi>
    <tradeName>BM Test HbA1c Reagent 1</tradeName>
    <deviceName>BM Test HbA1c Reagent 1</deviceName>
    <manufacturerName>JEOL Ltd. MF</manufacturerName>
    <manufacturerSrn>JP-MF-000026608</manufacturerSrn>
    <authorisedRepresentativeName>JEOL(Europe)BV AR</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023086</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>780609956</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:29.190Z</lastUpdated>
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  <row>
    <udiDi>42625753901532</udiDi>
    <basicUdiDi>B-42625753901532</basicUdiDi>
    <tradeName>Chromatographic Column (HPLC) Z-Hb Confirm</tradeName>
    <deviceName>Chromatographic Column (HPLC) Z-Hb Confirm</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RHBCC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:51.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1606T</udiDi>
    <basicUdiDi>B-1606T</basicUdiDi>
    <tradeName>D-1606T</tradeName>
    <deviceName>Hemoglobin A1c Kit (Enzymatic Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:57.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11R8E</udiDi>
    <basicUdiDi>B-11R8E</basicUdiDi>
    <tradeName>D-11R8E</tradeName>
    <deviceName>Hemoglobin A1c Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:49.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809328960865</udiDi>
    <basicUdiDi>B-08809328960865</basicUdiDi>
    <tradeName>ASUREQUAN HbA1c</tradeName>
    <deviceName>ASUREQUAN HbA1c</deviceName>
    <manufacturerName>EMPECS Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000029619</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP501001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:50.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115907134</udiDi>
    <basicUdiDi>B-08809115907134</basicUdiDi>
    <tradeName>CLOVER A1c Plus Test Cartridge</tradeName>
    <deviceName>CLOVER A1c Plus Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OHHS03A</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:56.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115906236</udiDi>
    <basicUdiDi>B-08809115906236</basicUdiDi>
    <tradeName>CLOVER A1c Plus Test Cartridge</tradeName>
    <deviceName>CLOVER A1c Plus Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OHHS03ASP</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:49.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115904911</udiDi>
    <basicUdiDi>B-08809115904911</basicUdiDi>
    <tradeName>CLOVER A1c Plus Test Cartridge</tradeName>
    <deviceName>CLOVER A1c Plus Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OHHS03ACZ</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:37.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115904881</udiDi>
    <basicUdiDi>B-08809115904881</basicUdiDi>
    <tradeName>CLOVER A1c Self Test Cartridge</tradeName>
    <deviceName>CLOVER A1c Self Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFHS02ASCZ</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:36.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115902559</udiDi>
    <basicUdiDi>B-08809115902559</basicUdiDi>
    <tradeName>HemoCue HbA1c 501 Test Cartridge</tradeName>
    <deviceName>HemoCue HbA1c 501 Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>405110</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:46.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115902092</udiDi>
    <basicUdiDi>B-08809115902092</basicUdiDi>
    <tradeName>CLOVER A1c Self Test Cartridge</tradeName>
    <deviceName>CLOVER A1c Self Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920404</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:44.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115901767</udiDi>
    <basicUdiDi>B-08809115901767</basicUdiDi>
    <tradeName>CLOVER A1c Self Test Cartridge</tradeName>
    <deviceName>CLOVER A1c Self Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFHS01AS2</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:41.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115902054</udiDi>
    <basicUdiDi>B-08809115902054</basicUdiDi>
    <tradeName>CLOVER A1c Self Test Cartridge</tradeName>
    <deviceName>CLOVER A1c Self Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920404</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:40.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115901019</udiDi>
    <basicUdiDi>B-08809115901019</basicUdiDi>
    <tradeName>CLOVER A1c Test Cartridge</tradeName>
    <deviceName>CLOVER A1c Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFHS02B</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:12.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800323056133</udiDi>
    <basicUdiDi>B-08800323056133</basicUdiDi>
    <tradeName>CLOVER A1c Plus Test Cartridge</tradeName>
    <deviceName>CLOVER A1c Plus Test Cartridge</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OHHS03A</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:22:34.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037900944</udiDi>
    <basicUdiDi>B-08800037900944</basicUdiDi>
    <tradeName>08800037900944</tradeName>
    <deviceName>SimplexTAS 101 HbA1c Reagent Cartridge</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0101002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:06:14.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015289535</udiDi>
    <basicUdiDi>B-08699015289535</basicUdiDi>
    <tradeName>HBA1C II DİREKT KİTİ</tradeName>
    <deviceName>HBA1C II DIRECT REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06R72-30</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:13:02.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015289528</udiDi>
    <basicUdiDi>B-08699015289528</basicUdiDi>
    <tradeName>HBA1C II DİREKT KİTİ</tradeName>
    <deviceName>HBA1C II DIRECT REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06R72-20</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:13:01.291Z</lastUpdated>
  </row>
</eudamedExport>