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    <tradeName>NGS Universal Index Kit (Illumina)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xukang Medical Technology (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017865</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
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    <reference>YK013-002M-CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:44:09.119Z</lastUpdated>
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    <udiDi>06974679040695</udiDi>
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    <tradeName>NGS Universal Index Kit (Illumina)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xukang Medical Technology (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017865</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <udiDi>06974679040701</udiDi>
    <basicUdiDi>697467904XKUDI0018AB</basicUdiDi>
    <tradeName>NGS Universal Index Kit (Illumina)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xukang Medical Technology (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017865</manufacturerSrn>
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    <deviceName>JKEasy Cell-free DNA Library Prep Kit</deviceName>
    <manufacturerName>Shenzhen Jingke Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038780</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:05:16.003Z</lastUpdated>
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    <udiDi>06976019890120</udiDi>
    <basicUdiDi>697601989OS004N5</basicUdiDi>
    <tradeName>Ultra-fast DNA Library Prep Kit</tradeName>
    <deviceName>Ultra-fast DNA Library Prep Kit</deviceName>
    <manufacturerName>Qitan Taike Biotechnology Ltd., Chengdu</manufacturerName>
    <manufacturerSrn>CN-MF-000040515</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS004011</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:38.328Z</lastUpdated>
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    <udiDi>06976019890113</udiDi>
    <basicUdiDi>697601989OS003N3</basicUdiDi>
    <tradeName>Flow Cell Wash Kit</tradeName>
    <deviceName>Flow Cell Wash Kit</deviceName>
    <manufacturerName>Qitan Taike Biotechnology Ltd., Chengdu</manufacturerName>
    <manufacturerSrn>CN-MF-000040515</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS003011</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:37.532Z</lastUpdated>
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    <udiDi>06976019890106</udiDi>
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    <tradeName>QPursue Dx DNA Sequencing Kit</tradeName>
    <deviceName>QPursue Dx DNA Sequencing Kit</deviceName>
    <manufacturerName>Qitan Taike Biotechnology Ltd., Chengdu</manufacturerName>
    <manufacturerSrn>CN-MF-000040515</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS002011</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:36.725Z</lastUpdated>
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    <udiDi>06976019890045</udiDi>
    <basicUdiDi>697601989OS001MX</basicUdiDi>
    <tradeName>QNome Dx DNA Sequencing Kit</tradeName>
    <deviceName>QNome Dx DNA Sequencing Kit</deviceName>
    <manufacturerName>Qitan Taike Biotechnology Ltd., Chengdu</manufacturerName>
    <manufacturerSrn>CN-MF-000040515</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OS001011</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:31.929Z</lastUpdated>
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    <udiDi>06975977120034</udiDi>
    <basicUdiDi>697597712CRC022-MBBU</basicUdiDi>
    <tradeName>06975977120034</tradeName>
    <deviceName>RNA Extraction Kit</deviceName>
    <manufacturerName>Shenzhen Genebiohealth Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046424</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRC022-MB</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:27:43.585Z</lastUpdated>
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    <udiDi>06975977120027</udiDi>
    <basicUdiDi>697597712CRC021-C2B</basicUdiDi>
    <tradeName>06975977120027</tradeName>
    <deviceName>RNA Extraction Kit</deviceName>
    <manufacturerName>Shenzhen Genebiohealth Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046424</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRC021-C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:27:41.876Z</lastUpdated>
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    <udiDi>06975608180864</udiDi>
    <basicUdiDi>697560818model04FF</basicUdiDi>
    <tradeName>Sequencing Reagent Kit</tradeName>
    <deviceName>Sequencing Reagent Kit</deviceName>
    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0864</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:22:42.251Z</lastUpdated>
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    <udiDi>06975489971162</udiDi>
    <basicUdiDi>697548997CDP804UA</basicUdiDi>
    <tradeName>TGuide S96 Magnetic Viral DNA/RNA Kit</tradeName>
    <deviceName>TGuide S96 Magnetic Viral DNA/RNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP804</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:21.206Z</lastUpdated>
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    <udiDi>06975489971155</udiDi>
    <basicUdiDi>697548997CDP604TY</basicUdiDi>
    <tradeName>TGuide S32 Magnetic Viral DNA/RNA Kit</tradeName>
    <deviceName>TGuide S32 Magnetic Viral DNA/RNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP604</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:20.392Z</lastUpdated>
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    <udiDi>06975489971124</udiDi>
    <basicUdiDi>697548997CDP438U7</basicUdiDi>
    <tradeName>Magnetic Viral DNA/RNA Kit</tradeName>
    <deviceName>Magnetic Viral DNA/RNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP438-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:19.596Z</lastUpdated>
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    <udiDi>06975489971100</udiDi>
    <basicUdiDi>697548997CDP362TX</basicUdiDi>
    <tradeName>Hi-Swab DNA Kit</tradeName>
    <deviceName>Hi-Swab DNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP362-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:15.589Z</lastUpdated>
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    <udiDi>06975489971087</udiDi>
    <basicUdiDi>697548997CDP348U5</basicUdiDi>
    <tradeName>TIANamp Blood DNA Kit</tradeName>
    <deviceName>TIANamp Blood DNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP348-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:14.790Z</lastUpdated>
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    <tradeName>TIANamp Stool DNA Kit</tradeName>
    <deviceName>TIANamp Stool DNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP328-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:14.006Z</lastUpdated>
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    <udiDi>06975489971063</udiDi>
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    <tradeName>TIANamp Micro DNA Kit</tradeName>
    <deviceName>TIANamp Micro DNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP316</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:13.192Z</lastUpdated>
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    <tradeName>TIANamp Hi-DNA/RNA Kit</tradeName>
    <deviceName>TIANamp Hi-DNA/RNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP315-T8</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:09.190Z</lastUpdated>
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    <udiDi>06975489971025</udiDi>
    <basicUdiDi>697548997CDP315TN</basicUdiDi>
    <tradeName>TIANamp Virus DNA/ RNA Kit</tradeName>
    <deviceName>TIANamp Virus DNA/ RNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP315</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:08.394Z</lastUpdated>
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