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    <tradeName>KMRtrack® KMR009</tradeName>
    <deviceName>KMRtrack® KMR009</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:08.745Z</lastUpdated>
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    <udiDi>D-8844342-04AX</udiDi>
    <basicUdiDi>B-8844342-04AX</basicUdiDi>
    <tradeName>KMRtrack® KMR004</tradeName>
    <deviceName>KMRtrack® KMR004</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <udiDi>D-8844342-11AU</udiDi>
    <basicUdiDi>B-8844342-11AU</basicUdiDi>
    <tradeName>KMRtrack® KMR011</tradeName>
    <deviceName>KMRtrack® KMR011</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <udiDi>D-8844342-10AS</udiDi>
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    <tradeName>KMRtrack® KMR010</tradeName>
    <deviceName>KMRtrack® KMR010</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8344342-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:06.366Z</lastUpdated>
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    <udiDi>D-88429825A</udiDi>
    <basicUdiDi>B-88429825A</basicUdiDi>
    <tradeName>KMRtrack® Monitoring Kit</tradeName>
    <deviceName>KMRtrack® Monitoring Kit</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8842982</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:48.672Z</lastUpdated>
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    <udiDi>D-88417814P</udiDi>
    <basicUdiDi>B-88417814P</basicUdiDi>
    <tradeName>KMRtype® Genotyping Kit</tradeName>
    <deviceName>KMRtype Genotyping Kit</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8841781</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:47.874Z</lastUpdated>
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    <udiDi>88000214000009</udiDi>
    <basicUdiDi>B-88000214000009</basicUdiDi>
    <tradeName>88000214000009</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DCGen Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026351</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DCOF</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:23:13.411Z</lastUpdated>
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    <udiDi>D-8344342-4982</udiDi>
    <basicUdiDi>B-8344342-4982</basicUdiDi>
    <tradeName>KMRtrack® KMR049</tradeName>
    <deviceName>KMRtrack® KMR049</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8344342-49</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:05.316Z</lastUpdated>
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    <udiDi>D-820133-1652G</udiDi>
    <basicUdiDi>B-820133-1652G</basicUdiDi>
    <tradeName>D-820133-1652G</tradeName>
    <deviceName>ApoE Genotype Test</deviceName>
    <manufacturerName>Laboratory Corporation of America Holdings</manufacturerName>
    <manufacturerSrn>US-MF-000017722</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>820133-165</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:18.618Z</lastUpdated>
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    <udiDi>D-7465934594DH</udiDi>
    <basicUdiDi>B-7465934594DH</basicUdiDi>
    <tradeName>OI-immune profiling assay</tradeName>
    <deviceName>OI-immune profiling assay</deviceName>
    <manufacturerName>Laboratory Corporation of America Holdings</manufacturerName>
    <manufacturerSrn>US-MF-000017722</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OI-IPA</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:08.103Z</lastUpdated>
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    <udiDi>08885013956047</udiDi>
    <basicUdiDi>B-08885013956047</basicUdiDi>
    <tradeName>Sentosa SQ Melanoma Panel (4x8)</tradeName>
    <deviceName>Sentosa SQ Melanoma Panel (4x8)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>690008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:39.608Z</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>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2331633</reference>
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    <lastUpdated>2026-07-09T16:05:16.127Z</lastUpdated>
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    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <reference>940-001459-00</reference>
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    <tradeName>Universal Sequencing Reaction Kit T7 FCL PE150</tradeName>
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    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
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    <tradeName>Universal Sequencing Reaction Kit T7 FCL PE150</tradeName>
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    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
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    <tradeName>Universal Sequencing Reaction Kit T7 FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
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    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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