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    <deviceName>High Myopia Risk Prediction Gene Test Kit (Gene sequencing)</deviceName>
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    <deviceName>High Myopia Risk Prediction Gene Test Kit (Gene sequencing)</deviceName>
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    <deviceName>Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)</deviceName>
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    <deviceName>Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>PSI Gene Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023276</manufacturerSrn>
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    <deviceName>Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>PSI Gene Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023276</manufacturerSrn>
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    <deviceName>Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>PSI Gene Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023276</manufacturerSrn>
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    <deviceName>Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>PSI Gene Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023276</manufacturerSrn>
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    <tradeName>16975843690019</tradeName>
    <deviceName>Corneal Dystrophy TGFBI Gene Testing Kit（Fluorescence PCR）</deviceName>
    <manufacturerName>PSI Gene Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023276</manufacturerSrn>
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    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:09:45.787Z</lastUpdated>
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    <tradeName>Ion Torrent™ Oncomine™ Dx Express Test Panel</tradeName>
    <deviceName>Ion Torrent™ Oncomine™ Dx Express Test Panel, a part of Ion Torrent™ Oncomine™ Dx Express Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50871 (A54103, A54103RR)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:40:19.485Z</lastUpdated>
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    <tradeName>Oncomine™ Dx Target DNA Control v2.0 Kit</tradeName>
    <deviceName>Oncomine™ Dx Target DNA Control v2.0 Kit, a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A44913 (A49756)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:40:00.287Z</lastUpdated>
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    <basicUdiDi>B-10190302015103</basicUdiDi>
    <tradeName>Oncomine™ Dx Target Test (DNA and RNA Panel)</tradeName>
    <deviceName>Oncomine™ Dx Target Test (DNA and RNA Panel), a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A32441 (A49756)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:39:56.289Z</lastUpdated>
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    <tradeName>Oncomine™ Dx Target RNA Control Diluent</tradeName>
    <deviceName>Oncomine™ Dx Target RNA Control Diluent, a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A38872 (A49756)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>Oncomine™ Solid Tumour Fusion Transcript Kit (Part 2 of 2)</tradeName>
    <deviceName>Oncomine™ Solid Tumour Fusion Transcript Kit (Part 2 of 2), a part of Oncomine™ Solid Tumour Kits</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2676202 (A26762)</reference>
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    <tradeName>Oncomine™ Solid Tumour Fusion Transcript Kit (Part 1 of 2)</tradeName>
    <deviceName>Oncomine™ Solid Tumour Fusion Transcript Kit (Part 1 of 2), a part of Oncomine™ Solid Tumour Kits</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <tradeName>Oncomine™ Solid Tumour DNA Kit (Part 2 of 2)</tradeName>
    <deviceName>Oncomine™ Solid Tumour DNA Kit (Part 2 of 2), a part of Oncomine™ Solid Tumour Kits</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2676102 (A26761)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>Oncomine™ Solid Tumour DNA Kit (Part 1 of 2)</tradeName>
    <deviceName>Oncomine™ Solid Tumour DNA Kit (Part 1 of 2), a part of Oncomine™ Solid Tumour Kits</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>Ion Torrent™ Dx No Template Control Kit</tradeName>
    <deviceName>Ion Torrent™ Dx No Template Control Kit, a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
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    <reference>A32444 (A49756)</reference>
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    <tradeName>Oncomine™ Dx Target RNA Control Kit</tradeName>
    <deviceName>Oncomine™ Dx Target RNA Control Kit, a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <deviceName>FMR1 CGG PCR</deviceName>
    <manufacturerName>Beijing Healthgene Laboratory Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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