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    <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>
    <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>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>
    <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>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>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4815</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:09.060Z</lastUpdated>
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    <udiDi>08809537078603</udiDi>
    <basicUdiDi>880953707K4814BG</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>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>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>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>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>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>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4614</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:06.386Z</lastUpdated>
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    <udiDi>08809357178316</udiDi>
    <basicUdiDi>880953707K4573BH</basicUdiDi>
    <tradeName>ExiPrep ™ 48 Viral RNA Kit</tradeName>
    <deviceName>ExiPrep™48 Viral RNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4573</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:04.781Z</lastUpdated>
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    <udiDi>08809357178309</udiDi>
    <basicUdiDi>880953707K4571BD</basicUdiDi>
    <tradeName>ExiPrep™ 48 Viral DNA/RNA Kit</tradeName>
    <deviceName>ExiPrep™ 48 Viral DNA/RNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4571</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:03.980Z</lastUpdated>
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    <udiDi>08809357178446</udiDi>
    <basicUdiDi>880953707K4574BK</basicUdiDi>
    <tradeName>ExiPrep™ 48 Genomic DNA Kit</tradeName>
    <deviceName>ExiPrep™48 Genomic DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4574</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:02.485Z</lastUpdated>
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    <udiDi>08809357174400</udiDi>
    <basicUdiDi>880953707K4474BE</basicUdiDi>
    <tradeName>ExiPrep™ Dx Blood Viral DNA Kit</tradeName>
    <deviceName>ExiPrep™ Dx Blood Viral DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4474</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:48.713Z</lastUpdated>
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    <udiDi>08809357174233</udiDi>
    <basicUdiDi>880953707K4418B4</basicUdiDi>
    <tradeName>ExiPrep™ Dx Mycobacteria Genomic DNA Kit</tradeName>
    <deviceName>ExiPrep™ Dx Mycobacteria Genomic DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4418</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:44.710Z</lastUpdated>
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  <row>
    <udiDi>08809357174219</udiDi>
    <basicUdiDi>880953707K4414AU</basicUdiDi>
    <tradeName>ExiPrep™ Dx Bacteria Genomic DNA Kit</tradeName>
    <deviceName>ExiPrep™ Dx Bacteria Genomic DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4414</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:43.915Z</lastUpdated>
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    <udiDi>08809357174196</udiDi>
    <basicUdiDi>880953707K4411AN</basicUdiDi>
    <tradeName>ExiPrep™ Dx Blood Genomic DNA Kit</tradeName>
    <deviceName>ExiPrep™ Dx Blood Genomic DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:43.108Z</lastUpdated>
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    <udiDi>08809357174172</udiDi>
    <basicUdiDi>880953707K4472BA</basicUdiDi>
    <tradeName>ExiPrep™ Dx Viral DNA Kit</tradeName>
    <deviceName>ExiPrep™ Dx Viral DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4472</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:42.304Z</lastUpdated>
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    <udiDi>08809357174158</udiDi>
    <basicUdiDi>880953707K4471B8</basicUdiDi>
    <tradeName>ExiPrep™ Dx Viral DNA/RNA Kit</tradeName>
    <deviceName>ExiPrep™ Dx Viral DNA/RNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4471</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:38.310Z</lastUpdated>
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    <udiDi>08809357174134</udiDi>
    <basicUdiDi>880953707K4473BC</basicUdiDi>
    <tradeName>ExiPrep™ Dx Viral RNA Kit</tradeName>
    <deviceName>ExiPrep™ Dx Viral RNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4473</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:37.514Z</lastUpdated>
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    <udiDi>08809357173526</udiDi>
    <basicUdiDi>880953707K3033M76</basicUdiDi>
    <tradeName>AccuPrep® Dx Viral RNA Extraction Kit</tradeName>
    <deviceName>AccuPrep® Dx Viral RNA Extraction Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-3033M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:36.706Z</lastUpdated>
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    <udiDi>08800242990143</udiDi>
    <basicUdiDi>880024299K45793S</basicUdiDi>
    <tradeName>ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit</tradeName>
    <deviceName>ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4579</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:36:16.539Z</lastUpdated>
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    <udiDi>08800242990235</udiDi>
    <basicUdiDi>880024299K44793M</basicUdiDi>
    <tradeName>ExiPrep™ Dx SF Mycobacteria Genomic DNA Kit</tradeName>
    <deviceName>ExiPrep™ Dx SF Mycobacteria Genomic DNA Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>K-4479</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:36:14.129Z</lastUpdated>
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