<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697603130A0113EYRH3D</udiDi>
    <basicUdiDi>B-697603130A0113EYRH3D</basicUdiDi>
    <tradeName>D-697603130A0113EYRH3D</tradeName>
    <deviceName>Human Papillomavirus 18 Types Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101A0113EY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:24.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130A0108EYS33J</udiDi>
    <basicUdiDi>B-697603130A0108EYS33J</basicUdiDi>
    <tradeName>D-697603130A0108EYS33J</tradeName>
    <deviceName>Human Papillomavirus 14 Types Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101A0108EY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:23.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840310948</udiDi>
    <basicUdiDi>B-69743840310948</basicUdiDi>
    <tradeName>HPV 16/18 Antigen Rapid Test</tradeName>
    <deviceName>HPV 16/18 Antigen 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>W0105041001</emdnCode>
    <emdnDescription>HPV ANTIGEN / ANTIBODIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3024301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:32.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AHPV23013ZTB</udiDi>
    <basicUdiDi>B-69509960AHPV23013ZTB</basicUdiDi>
    <tradeName>D-69509960AHPV23013ZTB</tradeName>
    <deviceName>Human Papillomavirus (23 types) Genotyping Kit  (Melt-Fluorescence PCR)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHPV2301-AOG48E,AHPV2301-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:48.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AHPV1801-BSKY7</udiDi>
    <basicUdiDi>B-69509960AHPV1801-BSKY7</basicUdiDi>
    <tradeName>D-69509960AHPV1801-BSKY7</tradeName>
    <deviceName>Human Papillomavirus (18 types) Genotyping Kit (Melt-Fluorescence PCR)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHPV1801-BOG48E，AHPV1801-BOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:46.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AHPV1801-ASHXU</udiDi>
    <basicUdiDi>B-69509960AHPV1801-ASHXU</basicUdiDi>
    <tradeName>D-69509960AHPV1801-ASHXU</tradeName>
    <deviceName>Human Papillomavirus 18 Types Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHPV1801-AOG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:44.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AHPV1401DDUBT</udiDi>
    <basicUdiDi>B-69509960AHPV1401DDUBT</basicUdiDi>
    <tradeName>D-69509960AHPV1401DDUBT</tradeName>
    <deviceName>Human Papillomavirus 14 Types Fluorescence PCR Kit (Lyophilized)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHPV1401D-AOG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:43.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AHPV14013XT5</udiDi>
    <basicUdiDi>B-69509960AHPV14013XT5</basicUdiDi>
    <tradeName>D-69509960AHPV14013XT5</tradeName>
    <deviceName>Human Papillomavirus 14 Types Detection Kit  (Fluorescence PCR)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHPV1401-AOG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:43.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>6970277510028JYX</udiDi>
    <basicUdiDi>B-6970277510028JYX</basicUdiDi>
    <tradeName>HPV Antigen Rapid Test Cassette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105041001</emdnCode>
    <emdnDescription>HPV ANTIGEN / ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THPV-502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:33.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940001179</udiDi>
    <basicUdiDi>B-07332940001179</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® HPV</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXHPV-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:17.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884999051249</udiDi>
    <basicUdiDi>0884999AMN0041WA</basicUdiDi>
    <tradeName>Alinity m</tradeName>
    <deviceName>ALINITY M HR HPV</deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N15-092</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:24:05.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884999047914</udiDi>
    <basicUdiDi>0884999AMN0915XN</basicUdiDi>
    <tradeName>Alinity m</tradeName>
    <deviceName>ALINITY M HR HPV</deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N15-080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:23:46.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TRMF000028405HPVGRT50MX</udiDi>
    <basicUdiDi>B-TRMF000028405HPVGRT50MX</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP HPV HR &amp; 6 /11 Genotyping 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>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPVG-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:34.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNVC-CED-07XE</udiDi>
    <basicUdiDi>B-TD-HNVC-CED-07XE</basicUdiDi>
    <tradeName>D-TD-HNVC-CED-07XE</tradeName>
    <deviceName>Human Papillomavirus 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>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:01.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA011UE</udiDi>
    <basicUdiDi>B-RA011UE</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>Human Papillomavirus Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</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>P122-02096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:52.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA005UK</udiDi>
    <basicUdiDi>B-RA005UK</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>Human Papillomavirus DNA Test Kit(Fluorescence Melting Curve Method)</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P122-08048; P122-08240; P122-08480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:40.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>PP09501HPV.L1.LFT93</udiDi>
    <basicUdiDi>B-PP09501HPV.L1.LFT93</basicUdiDi>
    <tradeName>Prevo-Check</tradeName>
    <deviceName>Prevo-Check HPV L1 Antibody Rapid Test</deviceName>
    <manufacturerName>Abviris Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041001</emdnCode>
    <emdnDescription>HPV ANTIGEN / ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LFT-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T14:10:54.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC80402-NW-50TM2</udiDi>
    <basicUdiDi>B-JC80402-NW-50TM2</basicUdiDi>
    <tradeName>Human Papillomavirus Real Time PCR Kit</tradeName>
    <deviceName>Human Papillomavirus 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>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC80402-NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:24:28.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC80301NW-48TW8</udiDi>
    <basicUdiDi>B-JC80301NW-48TW8</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Real Time PCR Kit</tradeName>
    <deviceName>Human Papillomavirus Genotyping 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>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC80301NW-48T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:24:24.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC80301NW-24TVJ</udiDi>
    <basicUdiDi>B-JC80301NW-24TVJ</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Real Time PCR Kit</tradeName>
    <deviceName>Human Papillomavirus Genotyping 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>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC80301NW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:24:24.150Z</lastUpdated>
  </row>
</eudamedExport>