<?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>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-HP12K2</udiDi>
    <basicUdiDi>B-HP12K2</basicUdiDi>
    <tradeName>Cowingene HPV Genotyping Detection Kit</tradeName>
    <deviceName>Cowingene HPV 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>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP12021X, HP13021V</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:31.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP11JY</udiDi>
    <basicUdiDi>B-HP11JY</basicUdiDi>
    <tradeName>Cowingene HPV 6/11 Detection Kit</tradeName>
    <deviceName>Cowingene HPV 6/11 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>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP11021X, HP11023W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:29.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP10JW</udiDi>
    <basicUdiDi>B-HP10JW</basicUdiDi>
    <tradeName>Cowingene HPV 16/18/45 Detection Kit</tradeName>
    <deviceName>Cowingene HPV 16/18/45 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>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP10023W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:29.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP05K5</udiDi>
    <basicUdiDi>B-HP05K5</basicUdiDi>
    <tradeName>Cowingene HPV 15 E6/E7 Gene mRNA  Detection Kit</tradeName>
    <deviceName>Cowingene HPV 15 E6/E7 Gene mRNA  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>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP05021X, HP05022X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:23.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002RHPV301RBBS</udiDi>
    <basicUdiDi>B-81649002RHPV301RBBS</basicUdiDi>
    <tradeName>D-81649002RHPV301RBBS</tradeName>
    <deviceName>Rapid Human Papillomavirus (16/18/45) DNA Test</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>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHPV301-AHG5E/RHPV301-AHG25E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:26.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002RHPV201R6AR</udiDi>
    <basicUdiDi>B-81649002RHPV201R6AR</basicUdiDi>
    <tradeName>D-81649002RHPV201R6AR</tradeName>
    <deviceName>Rapid Human Papillomavirus (6/11) DNA Test</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>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHPV201-AHG5E/RHPV201-AHG25E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:25.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AHPV1801AVBRB</udiDi>
    <basicUdiDi>B-81649002AHPV1801AVBRB</basicUdiDi>
    <tradeName>D-81649002AHPV1801AVBRB</tradeName>
    <deviceName>Human Papillomavirus 18 Types Detection Kit (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>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHPV1801-AHG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:07.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>16955792730639</udiDi>
    <basicUdiDi>B-16955792730639</basicUdiDi>
    <tradeName>15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3360E-12-P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:12:14.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>16955792730622</udiDi>
    <basicUdiDi>B-16955792730622</basicUdiDi>
    <tradeName>15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3360E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:12:13.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042229428</udiDi>
    <basicUdiDi>B-06971042229428</basicUdiDi>
    <tradeName>HPV6&amp;11 Real Time PCR Kit</tradeName>
    <deviceName>HPV6&amp;11 Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0018-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:11.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974737220861</udiDi>
    <basicUdiDi>697473722HPVRT2XS</basicUdiDi>
    <tradeName>06974737220861</tradeName>
    <deviceName>AmpSure® HPV Assay</deviceName>
    <manufacturerName>Shanghai Rendu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018869</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPVRT2-100CE</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:11.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970877681333</udiDi>
    <basicUdiDi>B-06970877681333</basicUdiDi>
    <tradeName>Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1203</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:21.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970877681326</udiDi>
    <basicUdiDi>B-06970877681326</basicUdiDi>
    <tradeName>Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:20.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970877681319</udiDi>
    <basicUdiDi>B-06970877681319</basicUdiDi>
    <tradeName>Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:19.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730632</udiDi>
    <basicUdiDi>B-06955792730632</basicUdiDi>
    <tradeName>15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3360E-12-P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:23.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730625</udiDi>
    <basicUdiDi>B-06955792730625</basicUdiDi>
    <tradeName>15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3360E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:20.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004480</udiDi>
    <basicUdiDi>B-06950996004480</basicUdiDi>
    <tradeName>Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)</tradeName>
    <deviceName>Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)</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>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2HPV29A11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:56.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884999047921</udiDi>
    <basicUdiDi>0884999AMN0915XN</basicUdiDi>
    <tradeName>Alinity m</tradeName>
    <deviceName></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>09N15-090</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:41.808Z</lastUpdated>
  </row>
</eudamedExport>