<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809240103722</udiDi>
    <basicUdiDi>924010HP10372FX</basicUdiDi>
    <tradeName>Allplex™ HPV28 Detection</tradeName>
    <deviceName>Allplex™ HPV28 Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP10372X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:36:24.899Z</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-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-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>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>
  <row>
    <udiDi>D-HP14025L8</udiDi>
    <basicUdiDi>B-HP14025L8</basicUdiDi>
    <tradeName>Cowingene HPV Genotyping Pro Detection Kit</tradeName>
    <deviceName>Cowingene HPV Genotyping Pro Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>HP14025V, HP14025Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:35.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP04K3</udiDi>
    <basicUdiDi>B-HP04K3</basicUdiDi>
    <tradeName>Cowingene HPV 28 Genotyping Detection Kit</tradeName>
    <deviceName>Cowingene HPV 28 Genotyping Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>HP04021V, HP04022S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:22.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M803921GA</udiDi>
    <basicUdiDi>B-G2M803921GA</basicUdiDi>
    <tradeName>HPV-Q comprehensive Real Time PCR Kit</tradeName>
    <deviceName>HPV-Q comprehensive Real Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2M803921,G2M803921R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:25.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295773148WYHA</udiDi>
    <basicUdiDi>B-84295773148WYHA</basicUdiDi>
    <tradeName>High + Low PapillomaStrip</tradeName>
    <deviceName>High + Low PapillomaStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>3.148.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:24.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AHPV2301M87N</udiDi>
    <basicUdiDi>B-81649002AHPV2301M87N</basicUdiDi>
    <tradeName>D-81649002AHPV2301M87N</tradeName>
    <deviceName>Human Papillomavirus (23 types) Genotyping Kit  (Melt-Fluorescence PCR)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</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-AHG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:12.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AHPV2301DURR7</udiDi>
    <basicUdiDi>B-81649002AHPV2301DURR7</basicUdiDi>
    <tradeName>D-81649002AHPV2301DURR7</tradeName>
    <deviceName>Human Papillomavirus 23 Types Genotyping Melt-Fluorescence PCR Kit (Lyophilized)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</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>AHPV2301D-AHG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:11.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AHPV1801MSAL</udiDi>
    <basicUdiDi>B-81649002AHPV1801MSAL</basicUdiDi>
    <tradeName>D-81649002AHPV1801MSAL</tradeName>
    <deviceName>Human Papillomavirus (18 types) Genotyping Kit(Melt-Fluorescence PCR)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</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-BHG48E,AHPV1801-BHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:08.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240103739</udiDi>
    <basicUdiDi>924010HP10372FX</basicUdiDi>
    <tradeName>Allplex™ HPV28 Detection</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP10373Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T14:47:11.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240103791</udiDi>
    <basicUdiDi>B-08809240103791</basicUdiDi>
    <tradeName>Anyplex™ II  HPV28 Detection</tradeName>
    <deviceName>Anyplex™ II  HPV28 Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>HP10379Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:45:37.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240100332</udiDi>
    <basicUdiDi>B-08809240100332</basicUdiDi>
    <tradeName>Anyplex™ II  HPV28 Detection</tradeName>
    <deviceName>Anyplex™ II  HPV28 Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>HP7S00X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:42:54.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500047</udiDi>
    <basicUdiDi>B-08800097500047</basicUdiDi>
    <tradeName>PaxView HPV20 Genotyping MPCR-ULFA Kit</tradeName>
    <deviceName>PaxView HPV20 Genotyping MPCR-ULFA Kit</deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>V0324</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:18.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500030</udiDi>
    <basicUdiDi>B-08800097500030</basicUdiDi>
    <tradeName>PaxView HPV16/18/Others MPCR-ULFA Kit</tradeName>
    <deviceName>PaxView HPV16/18/Others MPCR-ULFA Kit</deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>V0301</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:17.528Z</lastUpdated>
  </row>
</eudamedExport>