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<eudamedExport entity="devices">
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    <udiDi>08885013953695</udiDi>
    <basicUdiDi>B-08885013953695</basicUdiDi>
    <tradeName>Sentosa SA HSV1/2 Controls Set (8x3)</tradeName>
    <deviceName>Sentosa SA HSV1/2 Controls Set (8x3)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300686</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:47.201Z</lastUpdated>
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  <row>
    <udiDi>08885013953671</udiDi>
    <basicUdiDi>B-08885013953671</basicUdiDi>
    <tradeName>Sentosa SA HSV1/2 PCR Test (4x48)</tradeName>
    <deviceName>Sentosa SA HSV1/2 PCR Test (4x48)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300671</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:28.909Z</lastUpdated>
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  <row>
    <udiDi>08885013953305</udiDi>
    <basicUdiDi>B-08885013953305</basicUdiDi>
    <tradeName>Sentosa SA HSV1/2 Quantitation Standards (2x13)</tradeName>
    <deviceName>Sentosa SA HSV1/2 Quantitation Standards (2x13)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300071</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:08.407Z</lastUpdated>
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  <row>
    <udiDi>08885013953251</udiDi>
    <basicUdiDi>B-08885013953251</basicUdiDi>
    <tradeName>Sentosa SA HSV1/2 Quantitation Controls (4x2)</tradeName>
    <deviceName>Sentosa SA HSV1/2 Quantitation Controls (4x2)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300072</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:05.897Z</lastUpdated>
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  <row>
    <udiDi>08885013953237</udiDi>
    <basicUdiDi>B-08885013953237</basicUdiDi>
    <tradeName>Sentosa SA HSV1/2 PCR Test (4x24)</tradeName>
    <deviceName>Sentosa SA HSV1/2 PCR Test (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300233</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:05.088Z</lastUpdated>
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  <row>
    <udiDi>08719327116128</udiDi>
    <basicUdiDi>B-08719327116128</basicUdiDi>
    <tradeName>STD-Finder® 2SMART</tradeName>
    <deviceName>STD-Finder® 2SMART</deviceName>
    <manufacturerName>PathoFinder B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF3200-2S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:20.951Z</lastUpdated>
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  <row>
    <udiDi>08697962616541</udiDi>
    <basicUdiDi>B-08697962616541</basicUdiDi>
    <tradeName>SOFTEC Herpes Simplex Virus (HSV-1 &amp; HSV-2) Qualitative RT-qPCR Detection Kit</tradeName>
    <deviceName>Herpes Simplex Virus (HSV-1 &amp; HSV-2) Qualitative RT-qPCR Detection Kit</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040399</emdnCode>
    <emdnDescription>HSV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZT-HSV-01-100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:04.789Z</lastUpdated>
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  <row>
    <udiDi>08684595034873</udiDi>
    <basicUdiDi>B-08684595034873</basicUdiDi>
    <tradeName>ChainFor HSV-6 Detection qPCR Kit</tradeName>
    <deviceName>HSV-6 Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:16:03.928Z</lastUpdated>
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  <row>
    <udiDi>08684595030615</udiDi>
    <basicUdiDi>B-08684595030615</basicUdiDi>
    <tradeName>RapidFor™ HSV (1/2) IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>HSV (1/2) IgG/IgM Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:14:33.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030455</udiDi>
    <basicUdiDi>B-08684595030455</basicUdiDi>
    <tradeName>RapidFor™ HSV-2 IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>HSV-2 IgG/IgM Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040310</emdnCode>
    <emdnDescription>HSV 2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:55.616Z</lastUpdated>
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  <row>
    <udiDi>08684595030448</udiDi>
    <basicUdiDi>B-08684595030448</basicUdiDi>
    <tradeName>RapidFor™ HSV-1 IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>HSV-1 IgG/IgM Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040307</emdnCode>
    <emdnDescription>HSV 1 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:54.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387213516</udiDi>
    <basicUdiDi>B-08684387213516</basicUdiDi>
    <tradeName>RevoDx HSV-2 qPCR Kit</tradeName>
    <deviceName>RevoDx HSV-2 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202233-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:57:22.049Z</lastUpdated>
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  <row>
    <udiDi>08684387213509</udiDi>
    <basicUdiDi>B-08684387213509</basicUdiDi>
    <tradeName>RevoDx HSV-1 qPCR Kit</tradeName>
    <deviceName>RevoDx HSV-1 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202232-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:57:21.242Z</lastUpdated>
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  <row>
    <udiDi>08683548259769</udiDi>
    <basicUdiDi>B-08683548259769</basicUdiDi>
    <tradeName>LyoSens Genital Ulcer Genotyping qPCR Kit</tradeName>
    <deviceName>Genital Ulcer Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO55</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:21:06.951Z</lastUpdated>
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  <row>
    <udiDi>08683548257819</udiDi>
    <basicUdiDi>B-08683548257819</basicUdiDi>
    <tradeName>ChainFor Genital Ulcer Genotyping Detection qPCR Kit</tradeName>
    <deviceName>Genital Ulcer Genotyping Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP83</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:17:04.796Z</lastUpdated>
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  <row>
    <udiDi>06942359552219</udiDi>
    <basicUdiDi>697015090000107H3</basicUdiDi>
    <tradeName>HSV-1 IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK0905</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:38:12.079Z</lastUpdated>
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    <udiDi>06942359552264</udiDi>
    <basicUdiDi>697015090000102GR</basicUdiDi>
    <tradeName>HSV-1 IgM CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040307</emdnCode>
    <emdnDescription>HSV 1 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK0405</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:38:12.037Z</lastUpdated>
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    <udiDi>06942359552318</udiDi>
    <basicUdiDi>697015090000108H5</basicUdiDi>
    <tradeName>HSV-2 IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK1005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:38:11.984Z</lastUpdated>
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  <row>
    <udiDi>06942359552363</udiDi>
    <basicUdiDi>697015090000103GT</basicUdiDi>
    <tradeName>HSV-2 IgM CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040310</emdnCode>
    <emdnDescription>HSV 2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK0505</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:38:11.927Z</lastUpdated>
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  <row>
    <udiDi>08595696304065</udiDi>
    <basicUdiDi>B-08595696304065</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Herpes Simplex Virus (HSV-1/2) PCR Kit</tradeName>
    <deviceName>GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58128</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:16.752Z</lastUpdated>
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