<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000014455-BF-S222RK</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S222RK</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S222RK</tradeName>
    <deviceName>Cys C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S222</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:52:56.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S221RH</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S221RH</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S221RH</tradeName>
    <deviceName>Cys C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S221</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:52:53.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840309126</udiDi>
    <basicUdiDi>B-69743840309126</basicUdiDi>
    <tradeName>Faecal Calprotectin Rapid Test</tradeName>
    <deviceName>Faecal Calprotectin Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3051001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:39.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69328692FI001MCGK</udiDi>
    <basicUdiDi>B-69328692FI001MCGK</basicUdiDi>
    <tradeName>Prostatic Exosomal Protein Quantitative Detection Kit (Fluorescence lmmunochromatography)</tradeName>
    <deviceName>Prostatic Exosomal Protein Quantitative Detection Kit (Fluorescence lmmunochromatography)</deviceName>
    <manufacturerName>Onco Biomedical Technology (Suzhou) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047590</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSEP-1030001T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:30.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69328692CG001KVF6</udiDi>
    <basicUdiDi>B-69328692CG001KVF6</basicUdiDi>
    <tradeName>Prostatic Exosomal Protein Qualitative Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>Prostatic Exosomal Protein Qualitative Detection Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Onco Biomedical Technology (Suzhou) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047590</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSEP-1030001T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:29.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-96AZ</udiDi>
    <basicUdiDi>B-6-96AZ</basicUdiDi>
    <tradeName>D-6-96AZ</tradeName>
    <deviceName>Serum Amyloid A(SAA)Assay Kit(Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000071M, USIA00000072M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:15:03.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-46AJ</udiDi>
    <basicUdiDi>B-6-46AJ</basicUdiDi>
    <tradeName>D-6-46AJ</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) testing kit (latex immunoturbidimetric method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U85782020M, U85781040M, U85789060M, U85785020M, U85720060M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:13:01.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-17AB</udiDi>
    <basicUdiDi>B-6-17AB</basicUdiDi>
    <tradeName>D-6-17AB</tradeName>
    <deviceName>Adenosine Deaminase Test Kit (Peroxidase Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U81382045M, U81389045M, U81385015M, U81320045M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:09:15.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-134FH</udiDi>
    <basicUdiDi>B-6-134FH</basicUdiDi>
    <tradeName>D-6-134FH</tradeName>
    <deviceName>Serum amyloid A(SAA)Test Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USCA00000745, USCA00000748 USCA00000746 USCA00000747, USCA00000749"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:58.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700823117</udiDi>
    <basicUdiDi>37017008IORO03DD</basicUdiDi>
    <tradeName>OROSOMUCOID IP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IORO-6125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700823124</udiDi>
    <basicUdiDi>37017008IORO03DD</basicUdiDi>
    <tradeName>OROSOMUCOID IP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IORO-5025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168016117</udiDi>
    <basicUdiDi>B-05415168016117</basicUdiDi>
    <tradeName>Cystatin C Gold Latex</tradeName>
    <deviceName>Cystatin C Gold Latex</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYDGX-H00/UDA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:55:08.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168016032</udiDi>
    <basicUdiDi>B-05415168016032</basicUdiDi>
    <tradeName>Calprotectin fecal</tradeName>
    <deviceName>Calprotectin fecal</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CACOL-H00/UDA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:55:05.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168015943</udiDi>
    <basicUdiDi>B-05415168015943</basicUdiDi>
    <tradeName>Cystatin C Gold Latex</tradeName>
    <deviceName>Cystatin C Gold Latex</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYDGX-L00/UDA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:59.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168015844</udiDi>
    <basicUdiDi>B-05415168015844</basicUdiDi>
    <tradeName>Calprotectin fecal</tradeName>
    <deviceName>Calprotectin fecal</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CACOL-L00/UDA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:56.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168015745</udiDi>
    <basicUdiDi>B-05415168015745</basicUdiDi>
    <tradeName>Cystatin C Gold Latex</tradeName>
    <deviceName>Cystatin C Gold Latex</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYDGX-B00/UDA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:52.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168015660</udiDi>
    <basicUdiDi>B-05415168015660</basicUdiDi>
    <tradeName>Calprotectin fecal</tradeName>
    <deviceName>Calprotectin fecal</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CACOL-B00/UDA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:49.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168015370</udiDi>
    <basicUdiDi>B-05415168015370</basicUdiDi>
    <tradeName>Cystatin C Gold Latex</tradeName>
    <deviceName>Cystatin C Gold Latex</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYDGX-L00/COB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:19.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168015363</udiDi>
    <basicUdiDi>B-05415168015363</basicUdiDi>
    <tradeName>Cystatin C Gold Latex</tradeName>
    <deviceName>Cystatin C Gold Latex</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYDGX-H00/COB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:18.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168015356</udiDi>
    <basicUdiDi>B-05415168015356</basicUdiDi>
    <tradeName>Cystatin C Gold Latex</tradeName>
    <deviceName>Cystatin C Gold Latex</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYDGX-B00/COB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:17.561Z</lastUpdated>
  </row>
</eudamedExport>