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<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>D-CNMF000014455-BF-C252NC</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C252NC</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C252NC</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-C252</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:03.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C251NA</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C251NA</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C251NA</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-C251</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:46:50.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C093NG</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C093NG</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C093NG</tradeName>
    <deviceName>ACR 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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C093</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:48.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C092NE</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C092NE</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C092NE</tradeName>
    <deviceName>ACR 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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C092</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:46.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C091NC</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C091NC</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C091NC</tradeName>
    <deviceName>ACR 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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C091</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:44.755Z</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>84352873309097</udiDi>
    <basicUdiDi>B-84352873309097</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>i-TRA Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060301</emdnCode>
    <emdnDescription>GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT31530</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:34:06.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873309080</udiDi>
    <basicUdiDi>B-84352873309080</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>i-TRA Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060301</emdnCode>
    <emdnDescription>GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR31536</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:34:03.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873309066</udiDi>
    <basicUdiDi>B-84352873309066</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>i-TRA Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060301</emdnCode>
    <emdnDescription>GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR31535</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:34:02.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873309059</udiDi>
    <basicUdiDi>B-84352873309059</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>i-TRA Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060301</emdnCode>
    <emdnDescription>GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR31532</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:34:01.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873309042</udiDi>
    <basicUdiDi>B-84352873309042</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>i-TRA Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060301</emdnCode>
    <emdnDescription>GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR31530</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:33:59.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873309035</udiDi>
    <basicUdiDi>B-84352873309035</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>i-TRA Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060301</emdnCode>
    <emdnDescription>GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3153032</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:33:56.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873309028</udiDi>
    <basicUdiDi>B-84352873309028</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>i-TRA Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060301</emdnCode>
    <emdnDescription>GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3153022</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:33:56.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873309011</udiDi>
    <basicUdiDi>B-84352873309011</basicUdiDi>
    <tradeName>84352873309011</tradeName>
    <deviceName>i-TRA Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060301</emdnCode>
    <emdnDescription>GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3153030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:33:55.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873309004</udiDi>
    <basicUdiDi>B-84352873309004</basicUdiDi>
    <tradeName>84352873309004</tradeName>
    <deviceName>i-TRA Turbidimetric</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060301</emdnCode>
    <emdnDescription>GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3153025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:33:54.191Z</lastUpdated>
  </row>
</eudamedExport>