<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06977568200101</udiDi>
    <basicUdiDi>B-06977568200101</basicUdiDi>
    <tradeName>06977568200101</tradeName>
    <deviceName>Fecal Calprotectin Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen Cavan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052933</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120 Tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:23:35.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977568200095</udiDi>
    <basicUdiDi>B-06977568200095</basicUdiDi>
    <tradeName>06977568200095</tradeName>
    <deviceName>Fecal Calprotectin Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen Cavan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052933</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1：2×15 mL、R2：2×4.2 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:23:35.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977568200088</udiDi>
    <basicUdiDi>B-06977568200088</basicUdiDi>
    <tradeName>06977568200088</tradeName>
    <deviceName>Fecal Calprotectin Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen Cavan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052933</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1：1×15 mL、R2：1×4.2 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:23:31.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753475232</udiDi>
    <basicUdiDi>B-06976753475232</basicUdiDi>
    <tradeName>Myoglobin/CK-MB/Troponin I Combo Rapid Test Device(serum/plasma/whole blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J030501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:58.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753473016</udiDi>
    <basicUdiDi>B-06976753473016</basicUdiDi>
    <tradeName>The CALP Rapid Test Device (Feces)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D030401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:23.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762913</udiDi>
    <basicUdiDi>B-06976202762913</basicUdiDi>
    <tradeName>Fetal Fibronectin (fFN) Rapid Test</tradeName>
    <deviceName>Fetal Fibronectin (fFN) Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHfFN-702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:24.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067858</udiDi>
    <basicUdiDi>B-06975984067858</basicUdiDi>
    <tradeName>Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320301303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:23:21.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067841</udiDi>
    <basicUdiDi>B-06975984067841</basicUdiDi>
    <tradeName>Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320301302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:23:19.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067834</udiDi>
    <basicUdiDi>B-06975984067834</basicUdiDi>
    <tradeName>Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320301301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:23:17.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067308</udiDi>
    <basicUdiDi>B-06975984067308</basicUdiDi>
    <tradeName>Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:22:17.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975838801768</udiDi>
    <basicUdiDi>B-06975838801768</basicUdiDi>
    <tradeName>06975838801768</tradeName>
    <deviceName>Heart-Type Fatty Acid Binding Protein Assay Kit</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:13:55.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323376</udiDi>
    <basicUdiDi>B-06975531323376</basicUdiDi>
    <tradeName>06975531323376</tradeName>
    <deviceName>Human Beta-amyloid (ABeta) test kit (Lateral flow immunochromatography assay)</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:23.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323369</udiDi>
    <basicUdiDi>B-06975531323369</basicUdiDi>
    <tradeName>06975531323369</tradeName>
    <deviceName>Human Beta-amyloid (ABeta) test kit (Lateral flow immunochromatography assay)</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:22.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323352</udiDi>
    <basicUdiDi>B-06975531323352</basicUdiDi>
    <tradeName>06975531323352</tradeName>
    <deviceName>Human Beta-amyloid (ABeta) test kit (Lateral flow immunochromatography assay)</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:21.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323345</udiDi>
    <basicUdiDi>B-06975531323345</basicUdiDi>
    <tradeName>06975531323345</tradeName>
    <deviceName>Human Beta-amyloid (ABeta) test kit (Lateral flow immunochromatography assay)</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:16.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975456580304</udiDi>
    <basicUdiDi>B-06975456580304</basicUdiDi>
    <tradeName>BNIBT</tradeName>
    <deviceName>Fetal Fibronectin (fFN) Rapid Test</deviceName>
    <manufacturerName>Beijing North Institute of Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008259</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFfFNC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:08.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424226906</udiDi>
    <basicUdiDi>B-06975424226906</basicUdiDi>
    <tradeName>IgG4 CLIA Assay Kit</tradeName>
    <deviceName>IgG4 CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20762EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:47.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225756</udiDi>
    <basicUdiDi>B-06975424225756</basicUdiDi>
    <tradeName>Cystatin C  Assay Kit（Fluorescence Immunoassay）</tradeName>
    <deviceName>Cystatin C  Assay Kit（Fluorescence Immunoassay）</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL246001C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:56.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225732</udiDi>
    <basicUdiDi>B-06975424225732</basicUdiDi>
    <tradeName>Calprotectin Assay kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Calprotectin Assay kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL245601C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:37.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225534</udiDi>
    <basicUdiDi>B-06975424225534</basicUdiDi>
    <tradeName>KL-6 Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>KL-6 Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL223501C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:05.322Z</lastUpdated>
  </row>
</eudamedExport>