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    <basicUdiDi>B-5713915SS014VCRK</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid KIT qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:49:02.747Z</lastUpdated>
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    <udiDi>D-5713915SS013VARA</udiDi>
    <basicUdiDi>B-5713915SS013VARA</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE KIT qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:49:01.485Z</lastUpdated>
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    <udiDi>D-5713915SS010V4Q3</udiDi>
    <basicUdiDi>B-5713915SS010V4Q3</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid PIK3CA qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:49:01.366Z</lastUpdated>
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    <udiDi>D-5713915SS007VFRZ</udiDi>
    <basicUdiDi>B-5713915SS007VFRZ</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE NRAS qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:57.556Z</lastUpdated>
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    <udiDi>D-5713915SS004V9QS</udiDi>
    <basicUdiDi>B-5713915SS004V9QS</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid EGFR qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:57.400Z</lastUpdated>
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  <row>
    <udiDi>D-5713915SS005VBRF</udiDi>
    <basicUdiDi>B-5713915SS005VBRF</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE KRAS qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:55.304Z</lastUpdated>
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    <udiDi>D-5713915SS003V7QH</udiDi>
    <basicUdiDi>B-5713915SS003V7QH</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE EGFR qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:55.237Z</lastUpdated>
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    <udiDi>D-5713915SS002V5Q8</udiDi>
    <basicUdiDi>B-5713915SS002V5Q8</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid BRAF qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5525; 5530; 5535; 5336; 5341; 5346</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:37.298Z</lastUpdated>
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    <udiDi>D-5713915SS001V3PX</udiDi>
    <basicUdiDi>B-5713915SS001V3PX</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE BRAF qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1398;1402;1400;1831;1836;1841</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:36.416Z</lastUpdated>
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    <udiDi>D-5713915CD006LLAP</udiDi>
    <basicUdiDi>B-5713915CD006LLAP</basicUdiDi>
    <tradeName>RespiDetect</tradeName>
    <deviceName>RespiDetect Respiratory Panel 1 RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8200, 8201</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:32.148Z</lastUpdated>
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    <udiDi>D-5713915CD005LJAE</udiDi>
    <basicUdiDi>B-5713915CD005LJAE</basicUdiDi>
    <tradeName>CoviFLU</tradeName>
    <deviceName>CoviFLU COVID-19 &amp; Influenza RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8177, 8180</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:31.340Z</lastUpdated>
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  <row>
    <udiDi>D-5713915CD002LC9H</udiDi>
    <basicUdiDi>B-5713915CD002LC9H</basicUdiDi>
    <tradeName>CoviDetect</tradeName>
    <deviceName>CoviDetec FAST COVID-19 Multiplex RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8016; 8018; 8022</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:30.843Z</lastUpdated>
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  <row>
    <udiDi>D-5713915CD001LA98</udiDi>
    <basicUdiDi>B-5713915CD001LA98</basicUdiDi>
    <tradeName>CoviDetect</tradeName>
    <deviceName>CoviDetect COVID-19 Multiplex RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8015, 8010, 8079</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:29.746Z</lastUpdated>
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  <row>
    <udiDi>5713915CD003LE9S</udiDi>
    <basicUdiDi>B-5713915CD003LE9S</basicUdiDi>
    <tradeName>CoviDetect</tradeName>
    <deviceName>CoviDetect™ ULTRA COVID-19 Multiplex RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8213, 8214</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:40:59.960Z</lastUpdated>
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    <udiDi>05713915000533</udiDi>
    <basicUdiDi>5713915BP001NK</basicUdiDi>
    <tradeName>BasePurifier</tradeName>
    <deviceName>BasePurifier™ 32 Nucleic Acid Extraction System 32 Oscillating Rods</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>715</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:31.946Z</lastUpdated>
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    <udiDi>05713915001417</udiDi>
    <basicUdiDi>5713915ED002M2</basicUdiDi>
    <tradeName>EpiDirect® MLH1 Methylation qPCR Assay</tradeName>
    <deviceName>EpiDirect® MLH1 Methylation qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8401;8400</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:30.343Z</lastUpdated>
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    <udiDi>05713915000557</udiDi>
    <basicUdiDi>5713915BT004PM</basicUdiDi>
    <tradeName>BaseTyper</tradeName>
    <deviceName>BaseTyper™ 96.4 Flexible Real-Time PCR System</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>759</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:29.550Z</lastUpdated>
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    <udiDi>05713915000540</udiDi>
    <basicUdiDi>5713915BT003PK</basicUdiDi>
    <tradeName>BaseTyper</tradeName>
    <deviceName>BaseTyper™ 96.6 Flexible Real-Time PCR System</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>758</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:28.854Z</lastUpdated>
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    <udiDi>05713915000526</udiDi>
    <basicUdiDi>5713915BP002NM</basicUdiDi>
    <tradeName>BasePurifier</tradeName>
    <deviceName>BasePurifier™ 96 Nucleic Acid Extraction System 96 Rotating Rods</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>719</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:15.077Z</lastUpdated>
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    <udiDi>05713915000519</udiDi>
    <basicUdiDi>5713915BP003NP</basicUdiDi>
    <tradeName>BasePurifier</tradeName>
    <deviceName>BasePurifier™ 48 Large Volume Nucleic Acid Extraction System 48 Rotating Rods</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>718</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:14.278Z</lastUpdated>
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