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<eudamedExport entity="devices">
  <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-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>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>D-81649002AHPV1801-C6P8A</udiDi>
    <basicUdiDi>B-81649002AHPV1801-C6P8A</basicUdiDi>
    <tradeName>D-81649002AHPV1801-C6P8A</tradeName>
    <deviceName>Human Papillomavirus (HR 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>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHPV1801-CHG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:06.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AHPV1401M67G</udiDi>
    <basicUdiDi>B-81649002AHPV1401M67G</basicUdiDi>
    <tradeName>D-81649002AHPV1401M67G</tradeName>
    <deviceName>Human Papillomavirus 14 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>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHPV1401-AHG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:04.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AHPV1401DUMQR</udiDi>
    <basicUdiDi>B-81649002AHPV1401DUMQR</basicUdiDi>
    <tradeName>D-81649002AHPV1401DUMQR</tradeName>
    <deviceName>Human Papillomavirus 14 Types 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>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHPV1401D-AHG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:00.737Z</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>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>09343044002427</udiDi>
    <basicUdiDi>B-09343044002427</basicUdiDi>
    <tradeName>High Risk HPV Genotyping 8-well</tradeName>
    <deviceName>Step 2 Plates for High Risk HPV Genotyping 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23201P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:43.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002434</udiDi>
    <basicUdiDi>B-09343044002434</basicUdiDi>
    <tradeName>High Risk HPV Genotyping 8-well</tradeName>
    <deviceName>Step 1 tubes for High Risk HPV Genotyping 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23201S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:41.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240103807</udiDi>
    <basicUdiDi>B-08809240103807</basicUdiDi>
    <tradeName>Anyplex™ II HPV HR Detection</tradeName>
    <deviceName>Anyplex™ II HPV HR 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>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP10380Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:45:37.890Z</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>08809240100356</udiDi>
    <basicUdiDi>B-08809240100356</basicUdiDi>
    <tradeName>Anyplex™ II HPV HR Detection</tradeName>
    <deviceName>Anyplex™ II HPV HR 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>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP7E00L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:42:52.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240100349</udiDi>
    <basicUdiDi>B-08809240100349</basicUdiDi>
    <tradeName>Anyplex™ II HPV HR Detection</tradeName>
    <deviceName>Anyplex™ II HPV HR 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>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP7E00X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:42:51.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300669</udiDi>
    <basicUdiDi>B-08800204300669</basicUdiDi>
    <tradeName>08800204300669</tradeName>
    <deviceName>RADI Human Papillomavirus Detection Kit</deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041099</emdnCode>
    <emdnDescription>HPV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:15:03.953Z</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>
</eudamedExport>