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    <basicUdiDi>B-08809539870137</basicUdiDi>
    <tradeName>HEMEaccuTest DNA</tradeName>
    <deviceName>HEMEaccuTest DNA</deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>NGB121V-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:10.078Z</lastUpdated>
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    <udiDi>08809539870106</udiDi>
    <basicUdiDi>B-08809539870106</basicUdiDi>
    <tradeName>BRCAaccuTest PLUS</tradeName>
    <deviceName>BRCAaccuTest PLUS</deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB112V-024</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:09.269Z</lastUpdated>
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    <udiDi>08809539870083</udiDi>
    <basicUdiDi>B-08809539870083</basicUdiDi>
    <tradeName>BRCAaccuTest PLUS</tradeName>
    <deviceName>BRCAaccuTest PLUS</deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB112V-012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:05.276Z</lastUpdated>
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    <udiDi>08809378688948</udiDi>
    <basicUdiDi>B-08809378688948</basicUdiDi>
    <tradeName>08809378688948</tradeName>
    <deviceName>PNAClamp™ KRAS Mutation Detection Kit (Ver.4)</deviceName>
    <manufacturerName>HLB PANAGENE</manufacturerName>
    <manufacturerSrn>KR-MF-000042004</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNAC-1006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:09.281Z</lastUpdated>
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    <udiDi>08809240103906</udiDi>
    <basicUdiDi>B-08809240103906</basicUdiDi>
    <tradeName>Anyplex™ II Thrombosis SNP Panel Assay</tradeName>
    <deviceName>Anyplex™ II Thrombosis SNP Panel 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS10390Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:01.952Z</lastUpdated>
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    <udiDi>08809240100417</udiDi>
    <basicUdiDi>B-08809240100417</basicUdiDi>
    <tradeName>Anyplex™ II Thrombosis SNP Panel Assay</tradeName>
    <deviceName>Anyplex™ II Thrombosis SNP Panel 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS7600X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:42:59.370Z</lastUpdated>
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    <udiDi>08809240100400</udiDi>
    <basicUdiDi>B-08809240100400</basicUdiDi>
    <tradeName>Anyplex™ II Thrombosis SNP Panel Assay</tradeName>
    <deviceName>Anyplex™ II Thrombosis SNP Panel 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS7600Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:42:58.132Z</lastUpdated>
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    <udiDi>08809115907356</udiDi>
    <basicUdiDi>B-08809115907356</basicUdiDi>
    <tradeName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</tradeName>
    <deviceName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-20.02B006-ABI</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:00:02.391Z</lastUpdated>
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    <udiDi>08809115907349</udiDi>
    <basicUdiDi>B-08809115907349</basicUdiDi>
    <tradeName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</tradeName>
    <deviceName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-20.02B006-ABF</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:00:01.573Z</lastUpdated>
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    <udiDi>08809115904355</udiDi>
    <basicUdiDi>B-08809115904355</basicUdiDi>
    <tradeName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</tradeName>
    <deviceName>GeneFinder HLA-ABCDRB1DQ RealAmp kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-20.02B006-CFX</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:58:00.994Z</lastUpdated>
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    <udiDi>08809115904324</udiDi>
    <basicUdiDi>B-08809115904324</basicUdiDi>
    <tradeName>GeneFinder HLA-B*57:01 RealAmp Kit</tradeName>
    <deviceName>GeneFinder HLA-B*57:01 RealAmp Kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-22.02B050</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:59.393Z</lastUpdated>
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    <udiDi>08809115900555</udiDi>
    <basicUdiDi>B-08809115900555</basicUdiDi>
    <tradeName>GeneFinder HLA-ABDR RealAmp Kit</tradeName>
    <deviceName>GeneFinder HLA-ABDR RealAmp Kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-10.02B020-ABI</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:56:48.083Z</lastUpdated>
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    <udiDi>08800323057109</udiDi>
    <basicUdiDi>B-08800323057109</basicUdiDi>
    <tradeName>GeneFinder HLA-B*51 RealAmp Kit</tradeName>
    <deviceName>GeneFinder HLA-B*51 RealAmp Kit</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFMR-09.02B100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:22:47.314Z</lastUpdated>
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    <udiDi>08800087700143</udiDi>
    <basicUdiDi>B-08800087700143</basicUdiDi>
    <tradeName>Droplex PIK3CA Mutation Test</tradeName>
    <deviceName>Droplex PIK3CA Mutation Test</deviceName>
    <manufacturerName>Gencurix, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034097</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD006</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:23:54.302Z</lastUpdated>
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    <udiDi>08800087700082</udiDi>
    <basicUdiDi>B-08800087700082</basicUdiDi>
    <tradeName>Droplex EGFR Mutation Test v2</tradeName>
    <deviceName>Droplex EGFR Mutation Test v2</deviceName>
    <manufacturerName>Gencurix, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034097</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD002</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:23:53.501Z</lastUpdated>
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    <udiDi>08800087700136</udiDi>
    <basicUdiDi>B-08800087700136</basicUdiDi>
    <tradeName>Droplex ESR1 Mutation Test</tradeName>
    <deviceName>Droplex ESR1 Mutation Test</deviceName>
    <manufacturerName>Gencurix, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034097</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:23:52.858Z</lastUpdated>
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    <udiDi>08720299843400</udiDi>
    <basicUdiDi>B-08720299843400</basicUdiDi>
    <tradeName>08720299843400</tradeName>
    <deviceName>PreCursor-M+</deviceName>
    <manufacturerName>Self-screen B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000040204</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QHR15100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:15:55.440Z</lastUpdated>
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    <udiDi>08719327031834</udiDi>
    <basicUdiDi>B-08719327031834</basicUdiDi>
    <tradeName>CeliaSCAN</tradeName>
    <deviceName>CeliaSCAN</deviceName>
    <manufacturerName>Microbe&amp;Lab B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005727</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2331633</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:16.127Z</lastUpdated>
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    <udiDi>08717973349358</udiDi>
    <basicUdiDi>B-08717973349358</basicUdiDi>
    <tradeName>MAF (16q23)/D16Z3</tradeName>
    <deviceName>MAF (16q23) / D16Z3</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-00116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:53.784Z</lastUpdated>
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    <udiDi>08717973349266</udiDi>
    <basicUdiDi>B-08717973349266</basicUdiDi>
    <tradeName>SE 17 (D17Z1) - XL</tradeName>
    <deviceName>ERBB2 (17q12) / SE 17 - XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-XL020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:53.090Z</lastUpdated>
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