<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000014455GUK-S031LC</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S031LC</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S031LC</tradeName>
    <deviceName>Blood Ketone 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:59.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-S034LJ</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S034LJ</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S034LJ</tradeName>
    <deviceName>Blood Ketone 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:58.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-S033LG</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S033LG</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S033LG</tradeName>
    <deviceName>Blood Ketone 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:54.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-S025LH</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S025LH</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S025LH</tradeName>
    <deviceName>Uric Acid 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:51.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-S024LF</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S024LF</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S024LF</tradeName>
    <deviceName>Uric Acid 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S024</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:47.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-S023LD</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S023LD</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S023LD</tradeName>
    <deviceName>Uric Acid 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S023</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:43.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-C014GU</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-C014GU</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-C014GU</tradeName>
    <deviceName>Multi Control Solution</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>W010106040201</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS POC CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-C014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:41.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-C015GW</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-C015GW</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-C015GW</tradeName>
    <deviceName>Multi Control Solution</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>W010106040201</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS POC CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-C015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:38.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-C013GS</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-C013GS</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-C013GS</tradeName>
    <deviceName>Multi Control Solution</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>W010106040201</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS POC CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-C013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:34.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-C012GQ</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-C012GQ</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-C012GQ</tradeName>
    <deviceName>Multi Control Solution</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>W010106040201</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS POC CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-C012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:32.365Z</lastUpdated>
  </row>
  <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-CNMF000014455-BF-S095S4</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S095S4</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S095S4</tradeName>
    <deviceName>Urine Microalbumin Creatinine Ratio 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>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S095</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:17.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S094S2</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S094S2</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S094S2</tradeName>
    <deviceName>Urine Microalbumin Creatinine Ratio 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>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S094</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:12.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S093RY</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S093RY</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S093RY</tradeName>
    <deviceName>Urine Microalbumin Creatinine Ratio 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>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S093</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:12.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S092RW</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S092RW</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S092RW</tradeName>
    <deviceName>Urine Microalbumin Creatinine Ratio 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>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S092</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:07.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C253NE</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C253NE</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C253NE</tradeName>
    <deviceName>HbA1c 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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C253</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:03.621Z</lastUpdated>
  </row>
</eudamedExport>