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<eudamedExport entity="devices">
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    <udiDi>06933289858472</udiDi>
    <basicUdiDi>B-06933289858472</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Cardiac Troponin T (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA01P0006</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:22:34.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858465</udiDi>
    <basicUdiDi>B-06933289858465</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA01P0005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:41.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858458</udiDi>
    <basicUdiDi>B-06933289858458</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA01P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:40.353Z</lastUpdated>
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  <row>
    <udiDi>06933289858335</udiDi>
    <basicUdiDi>B-06933289858335</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Central Nervous System Specific Protein S100β (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021702</emdnCode>
    <emdnDescription>PROTEIN S-100 B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W498P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:39.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858199</udiDi>
    <basicUdiDi>B-06933289858199</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>H.pylori Antibody (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W493P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:38.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858182</udiDi>
    <basicUdiDi>B-06933289858182</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>H.pylori Antibody (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W493P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:23.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858175</udiDi>
    <basicUdiDi>B-06933289858175</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>H.pylori Antibody (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W493P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:22.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858168</udiDi>
    <basicUdiDi>B-06933289858168</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>H.pylori Antibody (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W493P0001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:21.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858038</udiDi>
    <basicUdiDi>B-06933289858038</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Fibrinogen/Fibrin Degradation Product (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W395P0007</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:21.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858021</udiDi>
    <basicUdiDi>B-06933289858021</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Fibrinogen/Fibrin Degradation Product (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W395P0006</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:17.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858014</udiDi>
    <basicUdiDi>B-06933289858014</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Fibrinogen/Fibrin Degradation Product (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W395P0005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:16.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289858007</udiDi>
    <basicUdiDi>B-06933289858007</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Fibrinogen/Fibrin Degradation Product (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W395P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:15.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289857994</udiDi>
    <basicUdiDi>B-06933289857994</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W394P0007</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:14.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289857987</udiDi>
    <basicUdiDi>B-06933289857987</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W394P0006</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:10.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289857970</udiDi>
    <basicUdiDi>B-06933289857970</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W394P0005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:09.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289857963</udiDi>
    <basicUdiDi>B-06933289857963</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W394P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:09.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289857833</udiDi>
    <basicUdiDi>B-06933289857833</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipid Carrier Protein (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W390P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:08.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289857826</udiDi>
    <basicUdiDi>B-06933289857826</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipid Carrier Protein (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W390P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:04.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289857819</udiDi>
    <basicUdiDi>B-06933289857819</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipid Carrier Protein (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W390P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:03.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289857802</udiDi>
    <basicUdiDi>B-06933289857802</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipid Carrier Protein (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W390P0001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-05T11:20:02.641Z</lastUpdated>
  </row>
</eudamedExport>