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    <tradeName>06974604720029</tradeName>
    <deviceName>Human BRAF Gene V600E Mutation Detection Kit (PCR-Fluorescence Method)</deviceName>
    <manufacturerName>Wuhan YZY Medical Science and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036323</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>YZYMT-003-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:03.523Z</lastUpdated>
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    <udiDi>06974604720012</udiDi>
    <basicUdiDi>B-06974604720012</basicUdiDi>
    <tradeName>06974604720012</tradeName>
    <deviceName>Human EGFR Gene Mutation Detection Kit (PCR-Fluorescence Method)</deviceName>
    <manufacturerName>Wuhan YZY Medical Science and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036323</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>YZYMT-002-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:02.722Z</lastUpdated>
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    <udiDi>06974323012870</udiDi>
    <basicUdiDi>B-06974323012870</basicUdiDi>
    <tradeName>06974323012870</tradeName>
    <deviceName>Human PIK3CA Gene Mutation Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>ID018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:06.572Z</lastUpdated>
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    <udiDi>06974323012849</udiDi>
    <basicUdiDi>B-06974323012849</basicUdiDi>
    <tradeName>06974323012849</tradeName>
    <deviceName>Human KRAS/NRAS/BRAF Gene Mutation Joint Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>ID016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:46.190Z</lastUpdated>
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    <udiDi>06974323012832</udiDi>
    <basicUdiDi>B-06974323012832</basicUdiDi>
    <tradeName>06974323012832</tradeName>
    <deviceName>Human IDH1 Gene Mutation Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>ID015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:44.324Z</lastUpdated>
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    <udiDi>06974323012788</udiDi>
    <basicUdiDi>B-06974323012788</basicUdiDi>
    <tradeName>06974323012788</tradeName>
    <deviceName>Human BRAF Gene V600E Mutation Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>ID012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:36.312Z</lastUpdated>
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    <udiDi>06974323012757</udiDi>
    <basicUdiDi>B-06974323012757</basicUdiDi>
    <tradeName>06974323012757</tradeName>
    <deviceName>EML4-ALK Fusion Gene Detection Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>ID010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:31.534Z</lastUpdated>
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    <udiDi>06974323012641</udiDi>
    <basicUdiDi>B-06974323012641</basicUdiDi>
    <tradeName>06974323012641</tradeName>
    <deviceName>Detection Kit for Five Mutated Genes</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>ID003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:13.119Z</lastUpdated>
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    <udiDi>06974323012627</udiDi>
    <basicUdiDi>B-06974323012627</basicUdiDi>
    <tradeName>06974323012627</tradeName>
    <deviceName>Detection Kit for 21 Mutations of Human EGFR Gene (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>ID001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:10.771Z</lastUpdated>
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    <udiDi>06972665700219</udiDi>
    <basicUdiDi>B-06972665700219</basicUdiDi>
    <tradeName>Breast-Ovarian Cancer Combined Gene Detection Kit</tradeName>
    <deviceName>Breast-Ovarian Cancer Combined Gene Detection Kit</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</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>SPG-BOC002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:43.723Z</lastUpdated>
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    <udiDi>06972665700004</udiDi>
    <basicUdiDi>B-06972665700004</basicUdiDi>
    <tradeName>Breast-Ovarian Cancer Combined Gene Detection Kit</tradeName>
    <deviceName>Breast-Ovarian Cancer Combined Gene Detection Kit</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</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>SPG-BOC001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:38.401Z</lastUpdated>
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    <udiDi>D-06971808256774W7</udiDi>
    <basicUdiDi>B-06971808256774W7</basicUdiDi>
    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>6q probe reagent</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</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>FP-006</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:04:29.819Z</lastUpdated>
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    <udiDi>04251315808799</udiDi>
    <basicUdiDi>B-04251315808799</basicUdiDi>
    <tradeName>XL TCRA/D</tradeName>
    <deviceName>XL TCRA/D</deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</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>D-5106-100-OG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:43:36.951Z</lastUpdated>
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    <udiDi>04251315808515</udiDi>
    <basicUdiDi>B-04251315808515</basicUdiDi>
    <tradeName>04251315808515</tradeName>
    <deviceName>XL t(7;12) MNX1/ETV6</deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</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>D-5101-100-OG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:43:35.346Z</lastUpdated>
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    <udiDi>04251315806108</udiDi>
    <basicUdiDi>B-04251315806108</basicUdiDi>
    <tradeName>XL Iso(17q)</tradeName>
    <deviceName>XL Iso(17q)</deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</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>D-5048-100-OG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:43:32.950Z</lastUpdated>
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    <udiDi>03770026953075</udiDi>
    <basicUdiDi>B-03770026953075</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>SarcomaFusion 48U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-SF48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:46.622Z</lastUpdated>
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    <udiDi>03770026953068</udiDi>
    <basicUdiDi>B-03770026953068</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>SarcomaFusion 24U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-SF24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:45.861Z</lastUpdated>
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    <udiDi>03770026953051</udiDi>
    <basicUdiDi>B-03770026953051</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>SarcomaFusion 16U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-SF16</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:45.035Z</lastUpdated>
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    <udiDi>03770026953044</udiDi>
    <basicUdiDi>B-03770026953044</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>SarcomaFusion 8U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-SF08</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:41.031Z</lastUpdated>
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    <basicUdiDi>B-03770026953037</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>LymphoSign 48U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-LS48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:40.236Z</lastUpdated>
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