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    <udiDi>08800111721991</udiDi>
    <basicUdiDi>88001117IPCA01MA18XR</basicUdiDi>
    <tradeName>STANDARD™ M10 Hr-HPV</tradeName>
    <deviceName>STANDARD™ M10 Hr-HPV</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11HPV20A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:58.393Z</lastUpdated>
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    <udiDi>08699863071740</udiDi>
    <basicUdiDi>869986307PHCPNZM</basicUdiDi>
    <tradeName>UniPatogen CerviPan HPV qPCR Screening Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000019285</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHCPN-250</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:57:25.951Z</lastUpdated>
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    <udiDi>08699863071733</udiDi>
    <basicUdiDi>869986307PHCPNZM</basicUdiDi>
    <tradeName>UniPatogen CerviPan HPV qPCR Screening Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000019285</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHCPN-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:57:24.755Z</lastUpdated>
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    <udiDi>08699863071726</udiDi>
    <basicUdiDi>869986307PHCPNZM</basicUdiDi>
    <tradeName>UniPatogen CerviPan HPV qPCR Screening Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000019285</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHCPN-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:57:17.550Z</lastUpdated>
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    <udiDi>08699863071672</udiDi>
    <basicUdiDi>869986307PHCPNZM</basicUdiDi>
    <tradeName>UniPatogen CerviPan HPV qPCR Screening Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000019285</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHCPN-1000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:57:16.357Z</lastUpdated>
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    <udiDi>08699863071665</udiDi>
    <basicUdiDi>869986307PHCPNZM</basicUdiDi>
    <tradeName>UniPatogen CerviPan HPV qPCR Screening Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PHARMALİNE SAĞLIK HİZMETLERİ SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000019285</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHCPN-500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:57:13.958Z</lastUpdated>
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    <udiDi>08057289090903</udiDi>
    <basicUdiDi>8057289090301CRT034ER</basicUdiDi>
    <tradeName>EasyPGX ready HPV</tradeName>
    <deviceName>EasyPGX ready HPV</deviceName>
    <manufacturerName>DIATECH PHARMACOGENETICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000018670</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>RTX034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:16.274Z</lastUpdated>
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    <udiDi>06974987420110</udiDi>
    <basicUdiDi>697498742KS3050013R</basicUdiDi>
    <tradeName>HPV Genotyping Kit (18 Types)</tradeName>
    <deviceName>HPV Genotyping Kit (18 Types)</deviceName>
    <manufacturerName>Guangzhou KingCreate Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032033</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</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>KS305-HPV48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:42.878Z</lastUpdated>
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    <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>
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    <udiDi>06974737220854</udiDi>
    <basicUdiDi>697473722HPV1618RT25E</basicUdiDi>
    <tradeName>06974737220854</tradeName>
    <deviceName>AmpSure® HPV 16/18 Genotype 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>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPV1618RT2-100CE</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:05.641Z</lastUpdated>
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    <udiDi>06973873140118</udiDi>
    <basicUdiDi>697387314DH3SQ</basicUdiDi>
    <tradeName>Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)</tradeName>
    <deviceName>Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)</deviceName>
    <manufacturerName>Hangzhou Dalton BioSciences, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036196</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>DH3-192</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:29.453Z</lastUpdated>
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    <udiDi>06973873140101</udiDi>
    <basicUdiDi>697387314DH3SQ</basicUdiDi>
    <tradeName>Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)</tradeName>
    <deviceName>Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)</deviceName>
    <manufacturerName>Hangzhou Dalton BioSciences, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036196</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>DH3-072</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:28.253Z</lastUpdated>
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  <row>
    <udiDi>06973873140026</udiDi>
    <basicUdiDi>697387314DH3SQ</basicUdiDi>
    <tradeName>Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)</tradeName>
    <deviceName>Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)</deviceName>
    <manufacturerName>Hangzhou Dalton BioSciences, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036196</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>DH3-096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:27.078Z</lastUpdated>
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    <udiDi>06973873140019</udiDi>
    <basicUdiDi>697387314DH3SQ</basicUdiDi>
    <tradeName>Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)</tradeName>
    <deviceName>Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)</deviceName>
    <manufacturerName>Hangzhou Dalton BioSciences, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036196</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>DH3-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:21.052Z</lastUpdated>
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    <udiDi>06970895477628</udiDi>
    <basicUdiDi>B-06970895477628</basicUdiDi>
    <tradeName>06970895477628</tradeName>
    <deviceName>Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>S02104T2096</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:52.253Z</lastUpdated>
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    <udiDi>06970895477611</udiDi>
    <basicUdiDi>B-06970895477611</basicUdiDi>
    <tradeName>06970895477611</tradeName>
    <deviceName>Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>S02104T2064</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:51.166Z</lastUpdated>
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    <udiDi>06970895477604</udiDi>
    <basicUdiDi>B-06970895477604</basicUdiDi>
    <tradeName>06970895477604</tradeName>
    <deviceName>Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>S02104T2048</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:48.660Z</lastUpdated>
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    <udiDi>06970895477598</udiDi>
    <basicUdiDi>B-06970895477598</basicUdiDi>
    <tradeName>06970895477598</tradeName>
    <deviceName>Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>S01502T2096</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:47.457Z</lastUpdated>
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    <udiDi>06970895477581</udiDi>
    <basicUdiDi>B-06970895477581</basicUdiDi>
    <tradeName>06970895477581</tradeName>
    <deviceName>Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>S01502T2064</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:41.518Z</lastUpdated>
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    <basicUdiDi>B-06970895477574</basicUdiDi>
    <tradeName>06970895477574</tradeName>
    <deviceName>Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>S01502T2048</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:40.253Z</lastUpdated>
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