<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000014455BF-C172CE</udiDi>
    <basicUdiDi>B-CNMF000014455BF-C172CE</basicUdiDi>
    <tradeName>D-CNMF000014455BF-C172CE</tradeName>
    <deviceName>HCY 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-C172</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:27.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-LA-C013QZ</udiDi>
    <basicUdiDi>B-CNMF000014455-LA-C013QZ</basicUdiDi>
    <tradeName>D-CNMF000014455-LA-C013QZ</tradeName>
    <deviceName>MMP-9 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>LA C013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:24.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-LA-C012QX</udiDi>
    <basicUdiDi>B-CNMF000014455-LA-C012QX</basicUdiDi>
    <tradeName>D-CNMF000014455-LA-C012QX</tradeName>
    <deviceName>MMP-9 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>LA C012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:18.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-LA-C011QV</udiDi>
    <basicUdiDi>B-CNMF000014455-LA-C011QV</basicUdiDi>
    <tradeName>D-CNMF000014455-LA-C011QV</tradeName>
    <deviceName>MMP-9 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>LA C011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:15.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C303N4</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C303N4</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C303N4</tradeName>
    <deviceName>fT4 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-C303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:46.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C302N2</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C302N2</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C302N2</tradeName>
    <deviceName>fT4 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-C302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:40.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C301MY</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C301MY</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C301MY</tradeName>
    <deviceName>fT4 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-C301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:38.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C293NS</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C293NS</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C293NS</tradeName>
    <deviceName>fT3 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-C293</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:38.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C292NQ</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C292NQ</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C292NQ</tradeName>
    <deviceName>fT3 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-C292</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:37.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C291NN</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C291NN</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C291NN</tradeName>
    <deviceName>fT3 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-C291</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:31.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C283NP</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C283NP</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C283NP</tradeName>
    <deviceName>T4 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-C283</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:30.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C282NM</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C282NM</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C282NM</tradeName>
    <deviceName>T4 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-C282</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:29.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C281NK</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C281NK</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C281NK</tradeName>
    <deviceName>T4 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-C281</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:27.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C271NG</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C271NG</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C271NG</tradeName>
    <deviceName>T3 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-C271</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:19.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C273NL</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C273NL</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C273NL</tradeName>
    <deviceName>T3 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 C27</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:18.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C272NJ</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C272NJ</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C272NJ</tradeName>
    <deviceName>T3 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-C272</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:18.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C263NH</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C263NH</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C263NH</tradeName>
    <deviceName>TSH 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-C263</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:15.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C262NF</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C262NF</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C262NF</tradeName>
    <deviceName>TSH 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-C262</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:04.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C261ND</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C261ND</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C261ND</tradeName>
    <deviceName>TSH 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-C261</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:04.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C243NB</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C243NB</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C243NB</tradeName>
    <deviceName>NGAL 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-C243</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:46:49.523Z</lastUpdated>
  </row>
</eudamedExport>