<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-YJB10312NW-25TW8</udiDi>
    <basicUdiDi>B-YJB10312NW-25TW8</basicUdiDi>
    <tradeName>Vibrio Cholerae Real Time PCR Kit</tradeName>
    <deviceName>Vibrio Cholerae Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJB10312NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:02:40.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YJB10144NW-50TXM</udiDi>
    <basicUdiDi>B-YJB10144NW-50TXM</basicUdiDi>
    <tradeName>Bartonella Real Time PCR Kit</tradeName>
    <deviceName>Bartonella Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJB10144NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:02:36.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YJB10144NW-25TXM</udiDi>
    <basicUdiDi>B-YJB10144NW-25TXM</basicUdiDi>
    <tradeName>Bartonella Real Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJB10144NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:02:35.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YJB10140NW-50TVH</udiDi>
    <basicUdiDi>B-YJB10140NW-50TVH</basicUdiDi>
    <tradeName>Shigella Dysenteriae Real Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJB10140NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:02:34.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YJB10140NW-25TVH</udiDi>
    <basicUdiDi>B-YJB10140NW-25TVH</basicUdiDi>
    <tradeName>Shigella Dysenteriae Real Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJB10140NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:02:34.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W135-C4U</udiDi>
    <basicUdiDi>B-W135-C4U</basicUdiDi>
    <tradeName>D-W135-C4U</tradeName>
    <deviceName>Diagnostic Kit for Human IgM Antibody of Chlamydia Pneumoniae (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010116</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONIAE ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W135-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:28:52.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID83-FK</udiDi>
    <basicUdiDi>B-VID83-FK</basicUdiDi>
    <tradeName>H.Pylori Antigen Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID83- 01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:32.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID82-FG</udiDi>
    <basicUdiDi>B-VID82-FG</basicUdiDi>
    <tradeName>H.Pylori Antibody Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID82- 01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:32.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405STI3RT50JS</udiDi>
    <basicUdiDi>B-TRMF000028405STI3RT50JS</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP STI Panel 3 Assay, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STI3-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:28.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405STI2RT50JF</udiDi>
    <basicUdiDi>B-TRMF000028405STI2RT50JF</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP STI Panel 2 Assay, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STI2-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:27.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405STI1RT50J4</udiDi>
    <basicUdiDi>B-TRMF000028405STI1RT50J4</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP STI Panel 1 Assay, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STI1-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:26.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405MTBXDRRTS7</udiDi>
    <basicUdiDi>B-TRMF000028405MTBXDRRTS7</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP MTB/XDR Detection Kit, 25T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTB/XDR-RT25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:53.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405MTBRT100HC</udiDi>
    <basicUdiDi>B-TRMF000028405MTBRT100HC</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP MTB Detection Kit, 100T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTB-RT100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:51.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405MTBNRT10LX</udiDi>
    <basicUdiDi>B-TRMF000028405MTBNRT10LX</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP MTB/NTM Detection Kit, 100T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTBN-RT100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:49.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405MTBMDRRTNE</udiDi>
    <basicUdiDi>B-TRMF000028405MTBMDRRTNE</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP MTB/MDR Detection Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTB/MDR-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:48.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405BORRT50LF</udiDi>
    <basicUdiDi>B-TRMF000028405BORRT50LF</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP Borrelia Detection Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010605</emdnCode>
    <emdnDescription>LYME DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BOR-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:54.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>TET01BK</udiDi>
    <basicUdiDi>B-TET01BK</basicUdiDi>
    <tradeName>TET01BK</tradeName>
    <deviceName>Tetanus Toxid IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011709</emdnCode>
    <emdnDescription>TETANUS (CLOSTRIDIUM T.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-TET01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:00:49.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNVC-CED-06XC</udiDi>
    <basicUdiDi>B-TD-HNVC-CED-06XC</basicUdiDi>
    <tradeName>D-TD-HNVC-CED-06XC</tradeName>
    <deviceName>Rifampicin-resistant Mycobacterium Tuberculosis Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Henan Vacure Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023292</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:01.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNVC-CED-04X8</udiDi>
    <basicUdiDi>B-TD-HNVC-CED-04X8</basicUdiDi>
    <tradeName>D-TD-HNVC-CED-04X8</tradeName>
    <deviceName>Beta-haemolytic Group B Streptococcus Nucleic Acid Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Henan Vacure Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023292</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:56.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNVC-CED-03X6</udiDi>
    <basicUdiDi>B-TD-HNVC-CED-03X6</basicUdiDi>
    <tradeName>D-TD-HNVC-CED-03X6</tradeName>
    <deviceName>Beta-haemolytic Group A Streptococcus Nucleic Acid Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Henan Vacure Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023292</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:55.505Z</lastUpdated>
  </row>
</eudamedExport>