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    <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>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2HPV29A01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:29.118Z</lastUpdated>
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    <udiDi>00810173656931</udiDi>
    <basicUdiDi>B-00810173656931</basicUdiDi>
    <tradeName>Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)</tradeName>
    <deviceName>Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2HPV18A01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:28.045Z</lastUpdated>
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    <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>
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    <udiDi>08685115804365</udiDi>
    <basicUdiDi>868521452PCR173GF</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName>HPV ID-14 Screening qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>CFP178P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:29:16.775Z</lastUpdated>
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    <udiDi>08685214527691</udiDi>
    <basicUdiDi>868521452PCR173GF</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>LYO178WS24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:49:40.938Z</lastUpdated>
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    <udiDi>08685214527714</udiDi>
    <basicUdiDi>868521452PCR173GF</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>LYO178WS48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:49:30.569Z</lastUpdated>
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    <udiDi>08685214527738</udiDi>
    <basicUdiDi>868521452PCR173GF</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>LYO178WS96</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:49:29.553Z</lastUpdated>
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    <udiDi>08685115804372</udiDi>
    <basicUdiDi>868521452PCR173GF</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>CFP178P50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:49:29.100Z</lastUpdated>
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    <udiDi>08685115804389</udiDi>
    <basicUdiDi>868521452PCR173GF</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>CFP178P100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:49:28.631Z</lastUpdated>
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    <udiDi>00382904437473</udiDi>
    <basicUdiDi>038290UDTHKMDJEX</basicUdiDi>
    <tradeName>VIPER</tradeName>
    <deviceName>BD Key Card for the BD Viper™ LT System</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041099</emdnCode>
    <emdnDescription>HPV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>443747</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:46:20.383Z</lastUpdated>
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    <udiDi>06260320417382</udiDi>
    <basicUdiDi>626032HI25GYV</basicUdiDi>
    <tradeName>Rastin</tradeName>
    <deviceName>Human Papillomavirus (HPV) Genotyping Real Time PCR kit</deviceName>
    <manufacturerName>Salamat Pajouhan  Rastin</manufacturerName>
    <manufacturerSrn>IR-MF-000054733</manufacturerSrn>
    <authorisedRepresentativeName>Source of Commerce GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050360</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>HI25G</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:31:31.806Z</lastUpdated>
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    <udiDi>06260320417375</udiDi>
    <basicUdiDi>626032HI50GYV</basicUdiDi>
    <tradeName>Rastin</tradeName>
    <deviceName>Human Papillomavirus (HPV) Genotyping Real Time PCR kit</deviceName>
    <manufacturerName>Salamat Pajouhan  Rastin</manufacturerName>
    <manufacturerSrn>IR-MF-000054733</manufacturerSrn>
    <authorisedRepresentativeName>Source of Commerce GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050360</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>HI50G</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:31:31.034Z</lastUpdated>
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    <udiDi>06260001187795</udiDi>
    <basicUdiDi>62600011ATK.HPV4D</basicUdiDi>
    <tradeName>ATK HPV</tradeName>
    <deviceName>HPV High Risk Real Time PCR Kit</deviceName>
    <manufacturerName>Arghavan Teb Kavian</manufacturerName>
    <manufacturerSrn>IR-MF-000045430</manufacturerSrn>
    <authorisedRepresentativeName>Medisol Technologies S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000044726</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>ATK.R011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:31:23.014Z</lastUpdated>
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    <udiDi>08684595034996</udiDi>
    <basicUdiDi>868521452PCR169GQ</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName>HPV ID-16 Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>CFP169P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:48:22.100Z</lastUpdated>
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    <udiDi>08685214527158</udiDi>
    <basicUdiDi>868521452PCR169GQ</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>LYO169WS24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:09:02.235Z</lastUpdated>
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    <udiDi>08685214527172</udiDi>
    <basicUdiDi>868521452PCR169GQ</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO169WS48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:09:01.956Z</lastUpdated>
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    <udiDi>08685214527196</udiDi>
    <basicUdiDi>868521452PCR169GQ</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>LYO169WS96</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:09:01.638Z</lastUpdated>
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    <basicUdiDi>868521452PCR169GQ</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP169P50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:09:01.146Z</lastUpdated>
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    <basicUdiDi>868521452PCR169GQ</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPF169P100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:09:01.001Z</lastUpdated>
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    <udiDi>D-THPV-502U3</udiDi>
    <basicUdiDi>B-THPV-502U3</basicUdiDi>
    <tradeName>HPV Antigen Rapid Test Cassette</tradeName>
    <deviceName>HPV Antigen Rapid Test Cassette</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>IVDD</legislation>
    <emdnCode>W0105041001</emdnCode>
    <emdnDescription>HPV ANTIGEN / ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THPV-502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-23T16:57:31.275Z</lastUpdated>
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