<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000014455-BF-S255S2</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S255S2</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S255S2</tradeName>
    <deviceName>HbA1c Test Kit (Fluorescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S255</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:39.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S254RY</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S254RY</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S254RY</tradeName>
    <deviceName>HbA1c Test Kit (Fluorescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S254</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:37.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S253RW</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S253RW</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S253RW</tradeName>
    <deviceName>HbA1c Test Kit (Fluorescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S253</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:34.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S252RU</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S252RU</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S252RU</tradeName>
    <deviceName>HbA1c Test Kit (Fluorescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S252</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:32.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S251RS</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S251RS</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S251RS</tradeName>
    <deviceName>HbA1c Test Kit (Fluorescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S251</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:53:29.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A076DG</udiDi>
    <basicUdiDi>B-A076DG</basicUdiDi>
    <tradeName>D-A076DG</tradeName>
    <deviceName>INDICAID® Glucose Rapid Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID® Glucose Rapid Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:40.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>G322001218BL8</udiDi>
    <basicUdiDi>++G322001218BL8</basicUdiDi>
    <tradeName>G322001218BL8</tradeName>
    <deviceName>ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)</deviceName>
    <manufacturerName>ProtectLife International Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000039217</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:36:07.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAI2022020HN</udiDi>
    <basicUdiDi>B-SAI2022020HN</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Glycated Hemoglobin Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAI2022020</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:47.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAI2022019J5</udiDi>
    <basicUdiDi>B-SAI2022019J5</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Glycated Hemoglobin Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAI2022019</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:47.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAI2022018J3</udiDi>
    <basicUdiDi>B-SAI2022018J3</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Glycated Hemoglobin Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAI2022018</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:40.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAI2022005HS</udiDi>
    <basicUdiDi>B-SAI2022005HS</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Glycated Hemoglobin Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAI2022005</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:26.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-MF-000015840BS</udiDi>
    <basicUdiDi>B-KR-MF-000015840BS</basicUdiDi>
    <tradeName>GREENCARE A1c Hemoglobin A1c Test Kit</tradeName>
    <deviceName>GREENCARE A1c Hemoglobin A1c Test Kit</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT100S10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:48.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIHBA-402aSW</udiDi>
    <basicUdiDi>B-FIHBA-402aSW</basicUdiDi>
    <tradeName>HbA1c Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>HbA1c Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIHBA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:28:52.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIHBA-402aHGPC</udiDi>
    <basicUdiDi>B-FIHBA-402aHGPC</basicUdiDi>
    <tradeName>HbA1c Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>HbA1c Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIHBA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:28:48.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-HBA-402HX</udiDi>
    <basicUdiDi>B-FI-HBA-402HX</basicUdiDi>
    <tradeName>D-FI-HBA-402HX</tradeName>
    <deviceName>HbA1c Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-HBA-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:47.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT007077</udiDi>
    <basicUdiDi>B-DT007077</basicUdiDi>
    <tradeName>Unicorn-HbA1c</tradeName>
    <deviceName>Unicorn-HbA1c</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0070</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:15:20.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT00066W</udiDi>
    <basicUdiDi>B-DT00066W</basicUdiDi>
    <tradeName>Unicorn-HbA1c</tradeName>
    <deviceName>Unicorn-HbA1c</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:14:12.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GCA-S31WG</udiDi>
    <basicUdiDi>B-CNMF000014455-GCA-S31WG</basicUdiDi>
    <tradeName>D-CNMF000014455-GCA-S31WG</tradeName>
    <deviceName>GluCoA1c Glycohemoglobin Test Kit</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>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCA-S31</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:20.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GCA-S33WL</udiDi>
    <basicUdiDi>B-CNMF000014455-GCA-S33WL</basicUdiDi>
    <tradeName>D-CNMF000014455-GCA-S33WL</tradeName>
    <deviceName>GluCoA1c Glycohemoglobin Test Kit</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>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCA-S33</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:20.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GCA-S23WH</udiDi>
    <basicUdiDi>B-CNMF000014455-GCA-S23WH</basicUdiDi>
    <tradeName>D-CNMF000014455-GCA-S23WH</tradeName>
    <deviceName>GluCoA1c Glycohemoglobin Test Kit</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>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCA-S23</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:14.130Z</lastUpdated>
  </row>
</eudamedExport>