<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-4-86X</udiDi>
    <basicUdiDi>B-4-86X</basicUdiDi>
    <tradeName>D-4-86X</tradeName>
    <deviceName>Hemoglobin Control Solution</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:16.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4-66T</udiDi>
    <basicUdiDi>B-4-66T</basicUdiDi>
    <tradeName>D-4-66T</tradeName>
    <deviceName>Hemoglobin Test Strip</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:09.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4-46P</udiDi>
    <basicUdiDi>B-4-46P</basicUdiDi>
    <tradeName>D-4-46P</tradeName>
    <deviceName>Blood Lipid Test Strip</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:08.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4-36M</udiDi>
    <basicUdiDi>B-4-36M</basicUdiDi>
    <tradeName>D-4-36M</tradeName>
    <deviceName>Blood Glucose Monitoring System Control Solution</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:06.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4-16H</udiDi>
    <basicUdiDi>B-4-16H</basicUdiDi>
    <tradeName>D-4-16H</tradeName>
    <deviceName>Blood Glucose Test Strip</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:02.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-38995JR</udiDi>
    <basicUdiDi>B-38995JR</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>38995</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:58:18.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34847HD</udiDi>
    <basicUdiDi>B-34847HD</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>34847</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:28:18.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33699HF</udiDi>
    <basicUdiDi>B-33699HF</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>33699</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:32.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>26935784411170</udiDi>
    <basicUdiDi>B-26935784411170</basicUdiDi>
    <tradeName>26935784411170</tradeName>
    <deviceName>A1cChek Express 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-S42</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:44:10.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>26935784400075</udiDi>
    <basicUdiDi>B-26935784400075</basicUdiDi>
    <tradeName>26935784400075</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-S32</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:44:06.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>26935784400068</udiDi>
    <basicUdiDi>B-26935784400068</basicUdiDi>
    <tradeName>26935784400068</tradeName>
    <deviceName>A1cChek Pro 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-S32</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:44:05.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>26935784400044</udiDi>
    <basicUdiDi>B-26935784400044</basicUdiDi>
    <tradeName>26935784400044</tradeName>
    <deviceName>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-S22</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:44:04.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>26935784400037</udiDi>
    <basicUdiDi>B-26935784400037</basicUdiDi>
    <tradeName>26935784400037</tradeName>
    <deviceName>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>A1C-S22</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:44:03.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935784450073</udiDi>
    <basicUdiDi>B-16935784450073</basicUdiDi>
    <tradeName>16935784450073</tradeName>
    <deviceName>Blood Glucose Test Strips</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-S42</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:58:13.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935784420052</udiDi>
    <basicUdiDi>B-16935784420052</basicUdiDi>
    <tradeName>16935784420052</tradeName>
    <deviceName>GluCoA1c Blood Glucose Test Strips</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-S32</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:58:03.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935784411173</udiDi>
    <basicUdiDi>B-16935784411173</basicUdiDi>
    <tradeName>16935784411173</tradeName>
    <deviceName>A1cChek Express 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-S42</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:58:02.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935784400078</udiDi>
    <basicUdiDi>B-16935784400078</basicUdiDi>
    <tradeName>16935784400078</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-S32</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:56.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935784400061</udiDi>
    <basicUdiDi>B-16935784400061</basicUdiDi>
    <tradeName>16935784400061</tradeName>
    <deviceName>A1cChek Pro 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-S32</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:54.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935784400054</udiDi>
    <basicUdiDi>B-16935784400054</basicUdiDi>
    <tradeName>16935784400054</tradeName>
    <deviceName>GluCoA1c Blood Glucose Test Strips</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-S22</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:52.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>16935784400030</udiDi>
    <basicUdiDi>B-16935784400030</basicUdiDi>
    <tradeName>16935784400030</tradeName>
    <deviceName>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>A1C-S22</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:50.843Z</lastUpdated>
  </row>
</eudamedExport>