<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000014455-BF-C162NA</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C162NA</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C162NA</tradeName>
    <deviceName>PCT/CRP Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C162</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:39.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C161N8</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C161N8</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C161N8</tradeName>
    <deviceName>PCT/CRP Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C161</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:38.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C153N9</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C153N9</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C153N9</tradeName>
    <deviceName>hs-cTnI Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C153</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:36.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C152N7</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C152N7</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C152N7</tradeName>
    <deviceName>hs-cTnI Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C152</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:34.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C151N5</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C151N5</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C151N5</tradeName>
    <deviceName>hs-cTnI Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C151</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:30.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C143N6</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C143N6</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C143N6</tradeName>
    <deviceName>Vitamin B12 Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C143</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:29.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C142N4</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C142N4</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C142N4</tradeName>
    <deviceName>Vitamin B12 Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C142</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:27.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C141N2</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C141N2</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C141N2</tradeName>
    <deviceName>Vitamin B12 Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C141</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:24.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C133N3</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C133N3</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C133N3</tradeName>
    <deviceName>Ferritin Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C133</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:22.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C132MZ</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C132MZ</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C132MZ</tradeName>
    <deviceName>Ferritin Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C132</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:21.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C131MX</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C131MX</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C131MX</tradeName>
    <deviceName>Ferritin Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C131</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:20.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C123MY</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C123MY</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C123MY</tradeName>
    <deviceName>Folic Acid Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C123</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:17.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C122MW</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C122MW</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C122MW</tradeName>
    <deviceName>Folic Acid Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C122</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:16.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C121MU</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C121MU</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C121MU</tradeName>
    <deviceName>Folic Acid Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C121</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:16.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C113MV</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C113MV</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C113MV</tradeName>
    <deviceName>25-OH Vitamin D Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C113</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:12.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C111MR</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C111MR</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C111MR</tradeName>
    <deviceName>25-OH Vitamin D Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:10.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C112MT</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C112MT</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C112MT</tradeName>
    <deviceName>25-OH Vitamin D Quality Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C112</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:09.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C103MS</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C103MS</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C103MS</tradeName>
    <deviceName>Microalbumin Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:08.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C102MQ</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C102MQ</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C102MQ</tradeName>
    <deviceName>Microalbumin Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:45:07.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C101MN</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C101MN</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C101MN</tradeName>
    <deviceName>Microalbumin Control</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>W0102160801</emdnCode>
    <emdnDescription>CONTROLS IMMUNOCHEM - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:48.502Z</lastUpdated>
  </row>
</eudamedExport>