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    <tradeName>iFlash-EB VCA IgG</tradeName>
    <deviceName>iFlash-EB VCA IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88006G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:19.353Z</lastUpdated>
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    <udiDi>06925912715689</udiDi>
    <basicUdiDi>692591270106H2</basicUdiDi>
    <tradeName>iFlash-Rubella IgM</tradeName>
    <deviceName>iFlash-Rubella IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040103</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88036M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:19.343Z</lastUpdated>
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    <udiDi>06925912715672</udiDi>
    <basicUdiDi>692591270105GY</basicUdiDi>
    <tradeName>iFlash-Rubella IgG</tradeName>
    <deviceName>iFlash-Rubella IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040102</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88035G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:13.896Z</lastUpdated>
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    <udiDi>06925912715665</udiDi>
    <basicUdiDi>692591270104GW</basicUdiDi>
    <tradeName>iFlash-CMV IgM</tradeName>
    <deviceName>iFlash-CMV IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88033M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:09.886Z</lastUpdated>
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    <udiDi>06925912715597</udiDi>
    <basicUdiDi>692591270062H7</basicUdiDi>
    <tradeName>iFlash-HSV-1 IgM</tradeName>
    <deviceName>iFlash-HSV-1 IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040307</emdnCode>
    <emdnDescription>HSV 1 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88041M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:07.491Z</lastUpdated>
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    <udiDi>06925912715580</udiDi>
    <basicUdiDi>692591270060H3</basicUdiDi>
    <tradeName>iFlash-HSV-2 IgM</tradeName>
    <deviceName>iFlash-HSV-2 IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040310</emdnCode>
    <emdnDescription>HSV 2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88039M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:29:52.247Z</lastUpdated>
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    <udiDi>06925912715573</udiDi>
    <basicUdiDi>692591270059HJ</basicUdiDi>
    <tradeName>iFlash-HSV-2 IgG</tradeName>
    <deviceName>iFlash-HSV-2 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88038G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:29:51.436Z</lastUpdated>
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    <udiDi>06925912715344</udiDi>
    <basicUdiDi>692591270061H5</basicUdiDi>
    <tradeName>iFlash-HSV-1 IgG</tradeName>
    <deviceName>iFlash-HSV-1 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88040G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:29:26.085Z</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>05944760250020</udiDi>
    <basicUdiDi>594476025TESTERAPIDEUY</basicUdiDi>
    <tradeName>ROTAVIRUS RAPID TEST CASSETTE (FECES)</tradeName>
    <deviceName>RAPID TEST CASSETTE</deviceName>
    <manufacturerName>Tody Laboratories Int. SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000032726</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C61RT1005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:27:35.616Z</lastUpdated>
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    <udiDi>05032384503827</udiDi>
    <basicUdiDi>5032384ImagenHSVVJ</basicUdiDi>
    <tradeName>IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPE 1 and 2</tradeName>
    <deviceName>IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPE 1 and 2</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040301</emdnCode>
    <emdnDescription>HSV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K610611-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:07.732Z</lastUpdated>
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    <udiDi>05056080500003</udiDi>
    <basicUdiDi>50560805PathoDXHerpesW5</basicUdiDi>
    <tradeName>PATHODX HERPES TYPING KIT</tradeName>
    <deviceName>PATHODX HERPES TYPING KIT</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040301</emdnCode>
    <emdnDescription>HSV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:50.271Z</lastUpdated>
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    <udiDi>08685115806710</udiDi>
    <basicUdiDi>868511580PCR138GU</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>UNKNOWN</legislation>
    <emdnCode>W0105040399</emdnCode>
    <emdnDescription>VARICELLA ZOSTER  - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO138WS24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:58:23.656Z</lastUpdated>
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    <udiDi>08685115806758</udiDi>
    <basicUdiDi>868511580PCR138GU</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>UNKNOWN</legislation>
    <emdnCode>W0105040399</emdnCode>
    <emdnDescription>VARICELLA ZOSTER  - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO138WS48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:58:19.306Z</lastUpdated>
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    <udiDi>08684595035719</udiDi>
    <basicUdiDi>868511580PCR138GU</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName>VZV 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>W0105040399</emdnCode>
    <emdnDescription>HSV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP138P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:58:18.590Z</lastUpdated>
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    <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>UNKNOWN</legislation>
    <emdnCode>W0105040399</emdnCode>
    <emdnDescription>VARICELLA ZOSTER  - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP138P50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:58:18.446Z</lastUpdated>
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    <basicUdiDi>868511580PCR138GU</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>UNKNOWN</legislation>
    <emdnCode>W0105040399</emdnCode>
    <emdnDescription>VARICELLA ZOSTER  - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPF138P100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:58:18.005Z</lastUpdated>
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    <basicUdiDi>868521452PCR171GB</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>W0105040104</emdnCode>
    <emdnDescription>RUBELLA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO171WS24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:44.769Z</lastUpdated>
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