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    <tradeName>TRUPCR® Viral RNA Extraction Kit</tradeName>
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    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-03T19:43:22.018Z</lastUpdated>
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    <tradeName>STABILYSE Prep Free</tradeName>
    <deviceName>STABILYSE Prep Free</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
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    <tradeName>Trueprep AUTO Universal Sample Pre-treatment Pack</tradeName>
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    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
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    <tradeName>Trueprep AUTO MTB Sample Pre-treatment Pack</tradeName>
    <deviceName>Trueprep AUTO MTB Sample Pre treatment Pack</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:12.531Z</lastUpdated>
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    <udiDi>08908007989880</udiDi>
    <basicUdiDi>8908007989880D4</basicUdiDi>
    <tradeName>Trueprep AUTO Universal Cartridge Based Sample Prep Kit</tradeName>
    <deviceName>Trueprep® AUTO Universal Cartridge Based Sample Prep Kit</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>60203AR25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
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    <udiDi>08908007989859</udiDi>
    <basicUdiDi>8908007989859DD</basicUdiDi>
    <tradeName>Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit</tradeName>
    <deviceName>Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60207AR50</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:06.138Z</lastUpdated>
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    <udiDi>08906178200667</udiDi>
    <basicUdiDi>890617820G2M232121F5</basicUdiDi>
    <tradeName>SpiNXT FFPE DNA Extraction Kit</tradeName>
    <deviceName>SpiNXT FFPE DNA Extraction Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:13.128Z</lastUpdated>
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    <basicUdiDi>890617820G2M810013GB</basicUdiDi>
    <tradeName>SpiNXT Cell free DNA Extraction  Kit</tradeName>
    <deviceName>SpiNXT Cell free DNA Extraction  Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M810013-50T</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:12.312Z</lastUpdated>
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    <udiDi>08906178200490</udiDi>
    <basicUdiDi>890617820G2M810007GG</basicUdiDi>
    <tradeName>MagNXT FFPE DNA Extraction Kit</tradeName>
    <deviceName>MagNXT FFPE DNA Extraction Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M810007-96T</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:11.512Z</lastUpdated>
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    <udiDi>08906178200384</udiDi>
    <basicUdiDi>890617820G2M212121EF</basicUdiDi>
    <tradeName>MagNXT Tissue &amp; body fluids Nucleic acid extraction kit</tradeName>
    <deviceName>MagNXT Tissue &amp; body fluids Nucleic acid extraction kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M212121-96T</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:07.525Z</lastUpdated>
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    <udiDi>08906178200148</udiDi>
    <basicUdiDi>890617820G2M131420EW</basicUdiDi>
    <tradeName>SpiNXT Tissue &amp; body fluids Nucleic acid extraction kit</tradeName>
    <deviceName>SpiNXT Tissue &amp; body fluids Nucleic acid extraction kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M131420-50T</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:05.911Z</lastUpdated>
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    <udiDi>08809537078733</udiDi>
    <basicUdiDi>880935717K4815BP</basicUdiDi>
    <tradeName>ExiStation™ FA DNA/RNA Kit (V3)</tradeName>
    <deviceName>ExiStation™ FA DNA/RNA Kit (V3)</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-4815</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:09.060Z</lastUpdated>
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    <udiDi>08809537078603</udiDi>
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    <tradeName>ExiStation™ FA DNA/RNA Kit (V2)</tradeName>
    <deviceName>ExiStation™ FA DNA/RNA Kit (V2)</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-4814</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:08.271Z</lastUpdated>
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    <udiDi>08809357179870</udiDi>
    <basicUdiDi>880953707K4611AY</basicUdiDi>
    <tradeName>ExiPrep™ 96 Genomic DNA Kit</tradeName>
    <deviceName>ExiPrep™ 96 Genomic DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-4611</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:10.386Z</lastUpdated>
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    <udiDi>08809357179498</udiDi>
    <basicUdiDi>880953707K3617B5</basicUdiDi>
    <tradeName>MagListo™ 5M Viral DNA/RNA Extraction Kit</tradeName>
    <deviceName>MagListo™ 5M Viral DNA/RNA Extraction Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-3617</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:08.789Z</lastUpdated>
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    <udiDi>08809357179481</udiDi>
    <basicUdiDi>880953707K4614B6</basicUdiDi>
    <tradeName>ExiPrep™ 96 Viral DNA/RNA Kit</tradeName>
    <deviceName>ExiPrep™ 96 Viral DNA/RNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>ExiPrep ™ 48 Viral RNA Kit</tradeName>
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    <manufacturerName>BIONEER Corporation</manufacturerName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-03T17:56:04.781Z</lastUpdated>
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    <tradeName>ExiPrep™ 48 Viral DNA/RNA Kit</tradeName>
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    <manufacturerName>BIONEER Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:03.980Z</lastUpdated>
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    <tradeName>ExiPrep™ 48 Genomic DNA Kit</tradeName>
    <deviceName>ExiPrep™48 Genomic DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
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    <tradeName>ExiPrep™ Dx Blood Viral DNA Kit</tradeName>
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    <manufacturerName>BIONEER Corporation</manufacturerName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:48.713Z</lastUpdated>
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