<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974674892503</udiDi>
    <basicUdiDi>B-06974674892503</basicUdiDi>
    <tradeName>Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:19.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892497</udiDi>
    <basicUdiDi>B-06974674892497</basicUdiDi>
    <tradeName>15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing)</tradeName>
    <deviceName>15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:18.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892480</udiDi>
    <basicUdiDi>B-06974674892480</basicUdiDi>
    <tradeName>HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit(PCR-Fluorescence Probing)</tradeName>
    <deviceName>HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit(PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:17.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892473</udiDi>
    <basicUdiDi>B-06974674892473</basicUdiDi>
    <tradeName>Ureaplasma urealyticum (UU) and Neisseria Gonorrhoeae (NG) Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Ureaplasma urealyticum (UU) and Neisseria Gonorrhoeae (NG) Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:13.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892466</udiDi>
    <basicUdiDi>B-06974674892466</basicUdiDi>
    <tradeName>GH FIA Kit</tradeName>
    <deviceName>GH FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0076</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:12.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892459</udiDi>
    <basicUdiDi>B-06974674892459</basicUdiDi>
    <tradeName>IGF-1 FIA Kit</tradeName>
    <deviceName>IGF-1 FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060403</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0075</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:11.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892442</udiDi>
    <basicUdiDi>B-06974674892442</basicUdiDi>
    <tradeName>Calprotectin FIA Kit</tradeName>
    <deviceName>Calprotectin FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</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>18-02-0074</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:11.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892435</udiDi>
    <basicUdiDi>B-06974674892435</basicUdiDi>
    <tradeName>Salmonella IgM FIA Kit</tradeName>
    <deviceName>Salmonella IgM FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011002</emdnCode>
    <emdnDescription>SALMONELLA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0073</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:25.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892428</udiDi>
    <basicUdiDi>B-06974674892428</basicUdiDi>
    <tradeName>Dengue IgG/IgM FIA Kit</tradeName>
    <deviceName>Dengue IgG/IgM FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0072</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:24.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892411</udiDi>
    <basicUdiDi>B-06974674892411</basicUdiDi>
    <tradeName>Dengue NS1 Ag FIA Kit</tradeName>
    <deviceName>Dengue NS1 Ag FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0071</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:24.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892404</udiDi>
    <basicUdiDi>B-06974674892404</basicUdiDi>
    <tradeName>MP IgM FIA Kit</tradeName>
    <deviceName>MP IgM FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:21.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892398</udiDi>
    <basicUdiDi>B-06974674892398</basicUdiDi>
    <tradeName>MP IgG FIA Kit</tradeName>
    <deviceName>MP IgG FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP IgG FIA Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:20.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892381</udiDi>
    <basicUdiDi>B-06974674892381</basicUdiDi>
    <tradeName>H. Pylori Ab FIA Kit</tradeName>
    <deviceName>H. Pylori Ab FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</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>18-02-0068</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:19.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892374</udiDi>
    <basicUdiDi>B-06974674892374</basicUdiDi>
    <tradeName>H. Pylori Ag FIA Kit</tradeName>
    <deviceName>H. Pylori Ag FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0067</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:17.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892367</udiDi>
    <basicUdiDi>B-06974674892367</basicUdiDi>
    <tradeName>Adenovirus FIA Kit</tradeName>
    <deviceName>Adenovirus FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0066</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:15.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892350</udiDi>
    <basicUdiDi>B-06974674892350</basicUdiDi>
    <tradeName>RSV FIA Kit</tradeName>
    <deviceName>RSV FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:13.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892343</udiDi>
    <basicUdiDi>B-06974674892343</basicUdiDi>
    <tradeName>FA FIA Kit</tradeName>
    <deviceName>FA FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0064</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:12.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892336</udiDi>
    <basicUdiDi>B-06974674892336</basicUdiDi>
    <tradeName>Intact-PTH FIA Kit</tradeName>
    <deviceName>Intact-PTH FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0063</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:11.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892329</udiDi>
    <basicUdiDi>B-06974674892329</basicUdiDi>
    <tradeName>C-peptide FIA Kit</tradeName>
    <deviceName>C-peptide FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0062</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:08.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892312</udiDi>
    <basicUdiDi>B-06974674892312</basicUdiDi>
    <tradeName>Insulin FIA Kit</tradeName>
    <deviceName>Insulin FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0061</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:07.349Z</lastUpdated>
  </row>
</eudamedExport>