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    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ106LE</reference>
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    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <udiDi>08435440212140</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>08435440212157</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ112HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:59.493Z</lastUpdated>
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    <udiDi>08435440212164</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ113LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:58.972Z</lastUpdated>
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    <udiDi>08435440212171</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ113HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:56.642Z</lastUpdated>
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    <udiDi>08594210150089</udiDi>
    <basicUdiDi>B-08594210150089</basicUdiDi>
    <tradeName>RT-PCR Respiratory panel 1: SARS-CoV-2/Flu/RSV</tradeName>
    <deviceName>RT-PCR Respiratory panel 1: SARS-CoV-2/Flu/RSV</deviceName>
    <manufacturerName>DIANA Biotechnologies, a.s</manufacturerName>
    <manufacturerSrn>CZ-MF-000022346</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB-1250-100rxns</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-18T07:18:54.647Z</lastUpdated>
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    <udiDi>D-SWx5-RTC(PRO)NF</udiDi>
    <basicUdiDi>B-SWx5-RTC(PRO)NF</basicUdiDi>
    <tradeName>Multi-Respiratory Antigen test (Swab)</tradeName>
    <deviceName>Multi-Respiratory Antigen test (Swab)</deviceName>
    <manufacturerName>Aceso Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045175</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWx5-RTC(PRO)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:41:12.002Z</lastUpdated>
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    <udiDi>D-SWx5-RTC(PLUS)DS</udiDi>
    <basicUdiDi>B-SWx5-RTC(PLUS)DS</basicUdiDi>
    <tradeName>Multi-Respiratory Antigen Test (Swab)</tradeName>
    <deviceName>Multi-Respiratory Antigen Test (Swab)</deviceName>
    <manufacturerName>Aceso Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045175</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWx5-RTC(PLUS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:41:11.904Z</lastUpdated>
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    <udiDi>09343044007743</udiDi>
    <basicUdiDi>B-09343044007743</basicUdiDi>
    <tradeName>RIDA®Plex Viral 12 well Step 2</tradeName>
    <deviceName>RIDA®Plex Viral 12 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27095P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:21:49.203Z</lastUpdated>
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    <udiDi>09343044007736</udiDi>
    <basicUdiDi>B-09343044007736</basicUdiDi>
    <tradeName>RIDA®Plex Viral 12 well Step 1</tradeName>
    <deviceName>RIDA®Plex Viral 12 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27095S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:21:49.109Z</lastUpdated>
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    <udiDi>D-IRTB-R555H2</udiDi>
    <basicUdiDi>B-IRTB-R555H2</basicUdiDi>
    <tradeName>Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test</tradeName>
    <deviceName>Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRTB-R555</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:09.026Z</lastUpdated>
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    <udiDi>D-IRTA-R555GM</udiDi>
    <basicUdiDi>B-IRTA-R555GM</basicUdiDi>
    <tradeName>Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test</tradeName>
    <deviceName>Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRTA-R555</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:08.726Z</lastUpdated>
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    <udiDi>D-IRTA-R545GJ</udiDi>
    <basicUdiDi>B-IRTA-R545GJ</basicUdiDi>
    <tradeName>Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test</tradeName>
    <deviceName>Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRTA-R545</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:07.741Z</lastUpdated>
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    <udiDi>D-69509960ACOV03RF4U</udiDi>
    <basicUdiDi>B-69509960ACOV03RF4U</basicUdiDi>
    <tradeName>D-69509960ACOV03RF4U</tradeName>
    <deviceName>SARS-CoV-2 Detection Kit (Fluorescence RT-PCR)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACOV03-AOG48E; ACOV03-AOG96E; ACOV03D-AOG48E; ACOV03D-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:19.284Z</lastUpdated>
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    <tradeName>D-69509960101A0227EYZSNY</tradeName>
    <deviceName>SARS-CoV-2 Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
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    <reference>101A0227EY</reference>
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    <lastUpdated>2026-07-17T00:52:11.398Z</lastUpdated>
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    <tradeName>Xpert®</tradeName>
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    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>XPRSFLU/RSV-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:52.163Z</lastUpdated>
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    <deviceName>STANDARD™ M10 Flu/RSV/SARS-CoV-2 Fast</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11FLU30A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:41:46.583Z</lastUpdated>
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    <manufacturerSrn>DE-MF-000017533</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FBC107-Cx</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:20:59.102Z</lastUpdated>
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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N79-092</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:24:11.435Z</lastUpdated>
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