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    <deviceName>HSV-1/2 IgG</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:53:06.653Z</lastUpdated>
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    <udiDi>D-EIM4202327F7</udiDi>
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    <tradeName>D-EIM4202327F7</tradeName>
    <deviceName>HSV-1/2 IgG</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <udiDi>D-EIM4201327EY</udiDi>
    <basicUdiDi>B-EIM4201327EY</basicUdiDi>
    <tradeName>D-EIM4201327EY</tradeName>
    <deviceName>HSV-1/2 IgM</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <udiDi>38594036041401</udiDi>
    <basicUdiDi>B-38594036041401</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-HSV 1+2 IgG</tradeName>
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    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</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>KZ-140-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:53:58.917Z</lastUpdated>
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    <udiDi>28594036043699</udiDi>
    <basicUdiDi>B-28594036043699</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-HSV 1+2 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</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>ODZ-369</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:51.244Z</lastUpdated>
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    <udiDi>28594036041695</udiDi>
    <basicUdiDi>B-28594036041695</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-HSV 1+2 IgG (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</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>ODZ-169</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:05.532Z</lastUpdated>
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    <udiDi>18594036041407</udiDi>
    <basicUdiDi>B-18594036041407</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-HSV 1+2 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:25:00.899Z</lastUpdated>
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    <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>
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    <udiDi>08594036043695</udiDi>
    <basicUdiDi>B-08594036043695</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-HSV 1+2 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</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>OD-369</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:45:21.438Z</lastUpdated>
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    <udiDi>08594036041691</udiDi>
    <basicUdiDi>B-08594036041691</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-HSV 1+2 IgG (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</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>OD-169</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:43:21.736Z</lastUpdated>
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    <udiDi>06976753478035</udiDi>
    <basicUdiDi>B-06976753478035</basicUdiDi>
    <tradeName>Herpes Simplex Virus -Ⅰ/Ⅱ IgG (HSV-Ⅰ/Ⅱ IgG) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KE003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:01:38.021Z</lastUpdated>
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    <udiDi>06971792053656</udiDi>
    <basicUdiDi>B-06971792053656</basicUdiDi>
    <tradeName>Herpes Simplex Virus -Ⅰ/Ⅱ IgG (HSV-Ⅰ/Ⅱ IgG) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KL009</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:56:47.274Z</lastUpdated>
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    <udiDi>08033891322212</udiDi>
    <basicUdiDi>803389132CHORUSHSG0093</basicUdiDi>
    <tradeName>CHORUS HERPES SIMPLEX 1+2 IgG</tradeName>
    <deviceName>CHORUS HERPES SIMPLEX 1+2 IgG</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:42:57.463Z</lastUpdated>
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    <udiDi>06903053039581</udiDi>
    <basicUdiDi>69449040AB74000135D</basicUdiDi>
    <tradeName>Herpes Simplex Virus 1+2 IgG（CLIA）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012494-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:49.812Z</lastUpdated>
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    <udiDi>06903053039642</udiDi>
    <basicUdiDi>69449040AB74000135D</basicUdiDi>
    <tradeName>Herpes Simplex Virus 1+2 IgG（CLIA）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012497-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:49.667Z</lastUpdated>
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    <udiDi>06903053039659</udiDi>
    <basicUdiDi>69449040AB74000135D</basicUdiDi>
    <tradeName>Herpes Simplex Virus 1+2 IgG（CLIA）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012495-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:49.642Z</lastUpdated>
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    <udiDi>06937339205179</udiDi>
    <basicUdiDi>B-06937339205179</basicUdiDi>
    <tradeName>VivaDiag Herpes Simplex Virus Type 1/2 IgG Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID135-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:58.871Z</lastUpdated>
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