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    <basicUdiDi>B-08908020139033</basicUdiDi>
    <tradeName>Truenat Dengue/Chikungunya</tradeName>
    <deviceName>Truenat Dengue/Chikungunya</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601040025</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:12.656Z</lastUpdated>
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    <udiDi>08908007989378</udiDi>
    <basicUdiDi>B-08908007989378</basicUdiDi>
    <tradeName>Truenat Dengue/Chikungunya</tradeName>
    <deviceName>Truenat Dengue/Chikungunya</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601040050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:30.464Z</lastUpdated>
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    <udiDi>08908007989361</udiDi>
    <basicUdiDi>B-08908007989361</basicUdiDi>
    <tradeName>Truenat Dengue/Chikungunya</tradeName>
    <deviceName>Truenat Dengue/Chikungunya</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601040020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:28.052Z</lastUpdated>
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    <udiDi>08908007989354</udiDi>
    <basicUdiDi>B-08908007989354</basicUdiDi>
    <tradeName>Truenat Dengue/Chikungunya</tradeName>
    <deviceName>Truenat Dengue/Chikungunya</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601040005, 601040020, 601040025, 601040050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:26.436Z</lastUpdated>
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    <udiDi>08885019710827</udiDi>
    <basicUdiDi>B-08885019710827</basicUdiDi>
    <tradeName>08885019710827</tradeName>
    <deviceName>abTES™  Flu/COVID-19 qPCR I Kit (100 Reactions)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>300144</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:49.892Z</lastUpdated>
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    <udiDi>08885019710810</udiDi>
    <basicUdiDi>B-08885019710810</basicUdiDi>
    <tradeName>08885019710810</tradeName>
    <deviceName>abTES™  Flu/COVID-19 qPCR I Kit (50 Reactions)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>300143</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:48.292Z</lastUpdated>
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    <udiDi>08885019710766</udiDi>
    <basicUdiDi>B-08885019710766</basicUdiDi>
    <tradeName>08885019710766</tradeName>
    <deviceName>abTES™ FLU/RSV qPCR I Kit (100 Reactions)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>300268</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:41.893Z</lastUpdated>
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    <udiDi>08885019710704</udiDi>
    <basicUdiDi>B-08885019710704</basicUdiDi>
    <tradeName>08885019710704</tradeName>
    <deviceName>abTES™ FLU/RSV qPCR I Kit (50 Reactions)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>300267</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:17.884Z</lastUpdated>
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    <udiDi>08885013953848</udiDi>
    <basicUdiDi>B-08885013953848</basicUdiDi>
    <tradeName>ViroKey Flu A/B &amp; RSV RT-PCR Extension Kit</tradeName>
    <deviceName>ViroKey Flu A/B &amp; RSV RT-PCR Extension Kit</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</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>301074</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:59.604Z</lastUpdated>
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    <udiDi>08809240103043</udiDi>
    <basicUdiDi>B-08809240103043</basicUdiDi>
    <tradeName>Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay</tradeName>
    <deviceName>Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>RV10349Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:45:24.281Z</lastUpdated>
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    <udiDi>08809240103036</udiDi>
    <basicUdiDi>B-08809240103036</basicUdiDi>
    <tradeName>Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay</tradeName>
    <deviceName>Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>RV10259X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:45:23.481Z</lastUpdated>
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  <row>
    <udiDi>08800204300232</udiDi>
    <basicUdiDi>B-08800204300232</basicUdiDi>
    <tradeName>08800204300232</tradeName>
    <deviceName>RADI FAST Flu-SC2-RSV Detection Kit</deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>RV013F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:42.349Z</lastUpdated>
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    <udiDi>08800204300218</udiDi>
    <basicUdiDi>B-08800204300218</basicUdiDi>
    <tradeName>08800204300218</tradeName>
    <deviceName>RADI FAST Flu-SC2 Detection Kit</deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV009F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:35.945Z</lastUpdated>
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    <udiDi>08800056369333</udiDi>
    <basicUdiDi>B-08800056369333</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B Multiplex Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ SARS-CoV-2, Influenza A&amp;B Multiplex Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>IR6903N</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:54.802Z</lastUpdated>
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    <udiDi>08800056369302</udiDi>
    <basicUdiDi>B-08800056369302</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B, RSV Multiplex Real-time PCR Kit II</tradeName>
    <deviceName>PowerChek™ SARS-CoV-2, Influenza A&amp;B, RSV Multiplex Real-time PCR Kit II</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>R6905Q</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:53.202Z</lastUpdated>
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    <udiDi>08800056369296</udiDi>
    <basicUdiDi>B-08800056369296</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B, RSV Multiplex Real-time PCR Kit II</tradeName>
    <deviceName>PowerChek™ SARS-CoV-2, Influenza A&amp;B, RSV Multiplex Real-time PCR Kit II</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>R6905N</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:52.403Z</lastUpdated>
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    <udiDi>08800056369234</udiDi>
    <basicUdiDi>B-08800056369234</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B Multiplex Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ SARS-CoV-2, Influenza A&amp;B Multiplex Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>IR6903Q</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:50.803Z</lastUpdated>
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    <udiDi>08800056369098</udiDi>
    <basicUdiDi>B-08800056369098</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B, RSV Multiplex Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ SARS-CoV-2, Influenza A&amp;B, RSV Multiplex Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>IR6904</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:46.810Z</lastUpdated>
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    <udiDi>08800056336007</udiDi>
    <basicUdiDi>B-08800056336007</basicUdiDi>
    <tradeName>PowerChek™ Influenza A&amp;B, RSV Multiplex Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ Influenza A&amp;B, RSV Multiplex Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>IR3600</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:33.992Z</lastUpdated>
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    <udiDi>08698898741055</udiDi>
    <basicUdiDi>B-08698898741055</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion Covidenza Plus QLP 3.0 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1390102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:31.716Z</lastUpdated>
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