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    <tradeName>HSV-1 IgG CLIA Microparticles</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:51:56.176Z</lastUpdated>
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    <udiDi>06903053039574</udiDi>
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    <tradeName>Herpes Simplex Virus-1 IgG（CLIA）</tradeName>
    <deviceName>Herpes Simplex Virus-1 IgG（CLIA）</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <lastUpdated>2026-07-31T16:49:18.176Z</lastUpdated>
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    <udiDi>06925912715344</udiDi>
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    <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>
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    <udiDi>D-R193153D</udiDi>
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    <deviceName>Herpes Simplex Virus type 1 Antibody IgG (HSV-1 IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:07:12.758Z</lastUpdated>
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    <udiDi>D-R193143B</udiDi>
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    <tradeName>D-R193143B</tradeName>
    <deviceName>Herpes Simplex Virus type 1 Antibody IgG (HSV-1 IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <lastUpdated>2026-07-22T12:07:11.978Z</lastUpdated>
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    <tradeName>D-R1931339</tradeName>
    <deviceName>Herpes Simplex Virus type 1 Antibody IgG (HSV-1 IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T12:07:11.159Z</lastUpdated>
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    <deviceName>Herpes Simplex Virus type 1 Antibody IgG (HSV-1 IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:07:10.710Z</lastUpdated>
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    <udiDi>D-R1931135</udiDi>
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    <tradeName>D-R1931135</tradeName>
    <deviceName>Herpes Simplex Virus type 1 Antibody IgG (HSV-1 IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R19311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:07:06.001Z</lastUpdated>
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    <udiDi>00842768022784</udiDi>
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    <tradeName>Atellica IM Herpes-1 IgG (HSV1)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_HSV1</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10733031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:32.143Z</lastUpdated>
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    <udiDi>00630414016740</udiDi>
    <basicUdiDi>0405686901815VX</basicUdiDi>
    <tradeName>ADVIA Centaur Herpes-1 IgG (HSV1)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_HSV1</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720846</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:10.506Z</lastUpdated>
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    <udiDi>+ENTIRE579010G</udiDi>
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    <tradeName>+ENTIRE579010G</tradeName>
    <deviceName>Herpes simplex Virus 1 (HSV 1) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE57901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:18:49.427Z</lastUpdated>
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    <udiDi>+ENTIHSV1G050DS06</udiDi>
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    <tradeName>+ENTIHSV1G050DS06</tradeName>
    <deviceName>NovaLisa® Herpes simplex Virus 1 (HSV 1) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSV1G050DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:33.722Z</lastUpdated>
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    <udiDi>+ENTIHSV1G050008</udiDi>
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    <tradeName>+ENTIHSV1G050008</tradeName>
    <deviceName>NovaLisa® Herpes simplex Virus 1 (HSV 1) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSV1G0500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:15.735Z</lastUpdated>
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    <udiDi>+ENTIEIA-419608</udiDi>
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    <tradeName>+ENTIEIA-419608</tradeName>
    <deviceName>Herpes Simplex Virus 1 IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-4196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:34.864Z</lastUpdated>
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    <udiDi>+ENTIDEHSV1G05000Z</udiDi>
    <basicUdiDi>B-+ENTIDEHSV1G05000Z</basicUdiDi>
    <tradeName>+ENTIDEHSV1G05000Z</tradeName>
    <deviceName>Herpes simplex Virus 1 (HSV 1) IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:10:56.194Z</lastUpdated>
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    <udiDi>D-VID133EU</udiDi>
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    <tradeName>VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA)</tradeName>
    <deviceName>VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID133-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:39.568Z</lastUpdated>
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    <udiDi>D-IM4415122JD</udiDi>
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    <tradeName>D-IM4415122JD</tradeName>
    <deviceName>HSV-1 IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <lastUpdated>2026-07-13T22:34:17.793Z</lastUpdated>
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    <deviceName>HSV-1 IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
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    <lastUpdated>2026-07-13T22:33:31.318Z</lastUpdated>
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    <deviceName>HSV-1 IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
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    <tradeName>D-IM4410122HA</tradeName>
    <deviceName>HSV-1 IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410122</reference>
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    <lastUpdated>2026-07-13T22:30:37.114Z</lastUpdated>
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