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    <tradeName>HSV-2 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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    <reference>CMK1003</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
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    <udiDi>06903053039529</udiDi>
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    <tradeName>Herpes Simplex Virus-2 IgG（CLIA）</tradeName>
    <deviceName>Herpes Simplex Virus-2 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>2026-07-31T16:49:13.877Z</lastUpdated>
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    <udiDi>06925912715573</udiDi>
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    <tradeName>iFlash-HSV-2 IgG</tradeName>
    <deviceName>iFlash-HSV-2 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
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    <udiDi>D-R1921436</udiDi>
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    <deviceName>Herpes Simplex Virus type 2 Antibody IgG (HSV-2 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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    <udiDi>D-R192163A</udiDi>
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    <tradeName>D-R192163A</tradeName>
    <deviceName>Herpes Simplex Virus type 2 Antibody IgG (HSV-2 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>2026-07-22T12:07:05.129Z</lastUpdated>
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    <udiDi>D-R1921538</udiDi>
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    <tradeName>D-R1921538</tradeName>
    <deviceName>Herpes Simplex Virus type 2 Antibody IgG (HSV-2 IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Herpes Simplex Virus type 2 Antibody IgG (HSV-2 IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T12:06:46.297Z</lastUpdated>
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    <deviceName>Herpes Simplex Virus type 2 Antibody IgG (HSV-2 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>2026-07-22T12:06:45.519Z</lastUpdated>
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    <udiDi>D-R192112Y</udiDi>
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    <deviceName>Herpes Simplex Virus type 2 Antibody IgG (HSV-2 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>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R19211</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:44.699Z</lastUpdated>
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    <udiDi>00842768022807</udiDi>
    <basicUdiDi>0405686901816VZ</basicUdiDi>
    <tradeName>Atellica IM Herpes-2 IgG (HSV2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_HSV2</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>
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    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10733033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:52:24.717Z</lastUpdated>
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    <udiDi>00630414016726</udiDi>
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    <tradeName>ADVIA Centaur Herpes-2 IgG (HSV2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_HSV2</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>
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    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720849</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:08.100Z</lastUpdated>
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    <deviceName>Herpes simplex Virus 2 (HSV 2) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:18:54.127Z</lastUpdated>
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    <tradeName>+ENTIHSV2G054DS0B</tradeName>
    <deviceName>NovaLisa® Herpes simplex Virus 2 (HSV 2) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:38.250Z</lastUpdated>
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    <udiDi>+ENTIHSV2G05400D</udiDi>
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    <tradeName>+ENTIHSV2G05400D</tradeName>
    <deviceName>NovaLisa® Herpes simplex Virus 2 (HSV 2) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <reference>HSV2G0540</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:32.654Z</lastUpdated>
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    <udiDi>+ENTIEIA-41980A</udiDi>
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    <deviceName>Herpes Simplex Virus 2 IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <reference>EIA-4198</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:36.466Z</lastUpdated>
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    <deviceName>Herpes simplex Virus 2 (HSV 2) IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-16T10:11:01.003Z</lastUpdated>
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    <udiDi>D-IM4415124JH</udiDi>
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    <tradeName>D-IM4415124JH</tradeName>
    <deviceName>HSV-2 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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    <deviceName>HSV-2 IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
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    <deviceName>HSV-2 IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
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    <deviceName>HSV-2 IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
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