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    <basicUdiDi>880953707RVP3116ZP</basicUdiDi>
    <tradeName>AccuPower® RV Kit (ExiStation™ FA 96)</tradeName>
    <deviceName>AccuPower® RV Kit (ExiStation™ FA 96)</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVP-3116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:13.865Z</lastUpdated>
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    <udiDi>08809537078412</udiDi>
    <basicUdiDi>880953707A20656V</basicUdiDi>
    <tradeName>ExiCycler™ V5 96</tradeName>
    <deviceName>ExiCycler™ V5</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>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2065-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:09.866Z</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>08809537078030</udiDi>
    <basicUdiDi>880953707A25001ZB</basicUdiDi>
    <tradeName>ExiStation™ FA 96</tradeName>
    <deviceName>ExiStation™ FA 96/384</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>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2500-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:07.468Z</lastUpdated>
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    <udiDi>08809537077866</udiDi>
    <basicUdiDi>880953707NCVM21111JH</basicUdiDi>
    <tradeName>AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit</tradeName>
    <deviceName>AccuPower® SARS-CoV-2 Real-Time RT-PCR 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCVM2-1111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:51.407Z</lastUpdated>
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    <udiDi>08809537072533</udiDi>
    <basicUdiDi>880953707QRV1113YY</basicUdiDi>
    <tradeName>IRON-qPCR™ RV Kit</tradeName>
    <deviceName>IRON-qPCR™ RV 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QRV-1113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:50.614Z</lastUpdated>
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  <row>
    <udiDi>08809537070744</udiDi>
    <basicUdiDi>880953707A26006X</basicUdiDi>
    <tradeName>IRON-qPCR™</tradeName>
    <deviceName>IRON-qPCR™</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>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:49.010Z</lastUpdated>
  </row>
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    <udiDi>08809537070188</udiDi>
    <basicUdiDi>880953707A52507F</basicUdiDi>
    <tradeName>ExiPrep™96 Lite</tradeName>
    <deviceName>ExiPrep™96 Lite</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>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-5250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:46.600Z</lastUpdated>
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    <udiDi>08809537070065</udiDi>
    <basicUdiDi>880953707A505075</basicUdiDi>
    <tradeName>ExiPrep™16 Dx</tradeName>
    <deviceName>ExiPrep™16 Dx</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>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-5050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:45.014Z</lastUpdated>
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    <udiDi>08809537070058</udiDi>
    <basicUdiDi>880953707A51507A</basicUdiDi>
    <tradeName>ExiPrep™48 Dx</tradeName>
    <deviceName>ExiPrep™48 Dx</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>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-5150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:44.196Z</lastUpdated>
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    <udiDi>08809537070034</udiDi>
    <basicUdiDi>880953707A20601Z6</basicUdiDi>
    <tradeName>Exicycler™ 96</tradeName>
    <deviceName>Exicycler™ 96</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>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2060-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:42.600Z</lastUpdated>
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  <row>
    <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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