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    <tradeName>Imegen-Quimera Screening Multiplex Plus II</tradeName>
    <deviceName>Imegen-Quimera Screening Multiplex Plus II</deviceName>
    <manufacturerName>Health in Code, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000054848</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMG-116-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:48:07.202Z</lastUpdated>
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    <udiDi>06975843690081</udiDi>
    <basicUdiDi>B-06975843690081</basicUdiDi>
    <tradeName>06975843690081</tradeName>
    <deviceName>High Myopia Risk Prediction Gene Test Kit (Gene sequencing)</deviceName>
    <manufacturerName>PSI Gene Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023276</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:18.380Z</lastUpdated>
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    <udiDi>06975843690074</udiDi>
    <basicUdiDi>B-06975843690074</basicUdiDi>
    <tradeName>06975843690074</tradeName>
    <deviceName>High Myopia Risk Prediction Gene Test Kit (Gene sequencing)</deviceName>
    <manufacturerName>PSI Gene Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023276</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:13.564Z</lastUpdated>
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    <udiDi>06974858560525</udiDi>
    <basicUdiDi>B-06974858560525</basicUdiDi>
    <tradeName>06974858560525</tradeName>
    <deviceName>Human ALDH2 Gene Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P133H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:59:01.712Z</lastUpdated>
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    <udiDi>06974689627282</udiDi>
    <basicUdiDi>B-06974689627282</basicUdiDi>
    <tradeName>Pharmacogenomic multi-gene digital PCR detection kit</tradeName>
    <deviceName>Pharmacogenomic multi-gene digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13310-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:49.090Z</lastUpdated>
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    <udiDi>06974689627275</udiDi>
    <basicUdiDi>B-06974689627275</basicUdiDi>
    <tradeName>Donor-derived cell-free DNA (dd-cfDNA) digital PCR detection kit</tradeName>
    <deviceName>Donor-derived cell-free DNA (dd-cfDNA) digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13311-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:48.276Z</lastUpdated>
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    <udiDi>06974689627060</udiDi>
    <basicUdiDi>B-06974689627060</basicUdiDi>
    <tradeName>BCR-ABL p190 digital PCR detection kit</tradeName>
    <deviceName>BCR-ABL p190 digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12904-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:08.245Z</lastUpdated>
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    <udiDi>06974689626551</udiDi>
    <basicUdiDi>B-06974689626551</basicUdiDi>
    <tradeName>Pharmacogenomic multi-gene digital PCR detection kit</tradeName>
    <deviceName>Pharmacogenomic multi-gene digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13310-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:38.991Z</lastUpdated>
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    <udiDi>06974689626544</udiDi>
    <basicUdiDi>B-06974689626544</basicUdiDi>
    <tradeName>Donor-derived cell-free DNA (dd-cfDNA) digital PCR detection kit</tradeName>
    <deviceName>Donor-derived cell-free DNA (dd-cfDNA) digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13311-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:38.198Z</lastUpdated>
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    <udiDi>06974689626070</udiDi>
    <basicUdiDi>B-06974689626070</basicUdiDi>
    <tradeName>BCR-ABL p190 digital PCR detection kit</tradeName>
    <deviceName>BCR-ABL p190 digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12904-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:09.367Z</lastUpdated>
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    <udiDi>06974604720159</udiDi>
    <basicUdiDi>B-06974604720159</basicUdiDi>
    <tradeName>06974604720159</tradeName>
    <deviceName>Human AGTR1 ACE ADRB1 CYP2D6 CYP2C9 Gene 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZYMT-025-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:17.935Z</lastUpdated>
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    <udiDi>06974604720074</udiDi>
    <basicUdiDi>B-06974604720074</basicUdiDi>
    <tradeName>06974604720074</tradeName>
    <deviceName>Human MTHFR Gene 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZYMT-014-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:10.734Z</lastUpdated>
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    <udiDi>06974604720067</udiDi>
    <basicUdiDi>B-06974604720067</basicUdiDi>
    <tradeName>06974604720067</tradeName>
    <deviceName>Human ALDH2 Gene 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZYMT-012-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:09.931Z</lastUpdated>
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    <udiDi>06974604720050</udiDi>
    <basicUdiDi>B-06974604720050</basicUdiDi>
    <tradeName>06974604720050</tradeName>
    <deviceName>Human SLCO1B1and ApoE Gene 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZYMT-011-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:09.156Z</lastUpdated>
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    <udiDi>06974323012771</udiDi>
    <basicUdiDi>B-06974323012771</basicUdiDi>
    <tradeName>06974323012771</tradeName>
    <deviceName>Human ALDH2 Gene Polymorphism 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:34.164Z</lastUpdated>
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    <udiDi>06974323012764</udiDi>
    <basicUdiDi>B-06974323012764</basicUdiDi>
    <tradeName>06974323012764</tradeName>
    <deviceName>Human ALDH2 Gene Polymorphism 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:32.320Z</lastUpdated>
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    <udiDi>06971532201675</udiDi>
    <basicUdiDi>B-06971532201675</basicUdiDi>
    <tradeName>06971532201675</tradeName>
    <deviceName>Hearing Loss Susceptibility HRM Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-HLS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:55.136Z</lastUpdated>
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    <udiDi>06971532201651</udiDi>
    <basicUdiDi>B-06971532201651</basicUdiDi>
    <tradeName>06971532201651</tradeName>
    <deviceName>SOX1 and PAX1 Methylation Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-CCDNAm</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:52.474Z</lastUpdated>
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    <basicUdiDi>B-06971532201668</basicUdiDi>
    <tradeName>06971532201668</tradeName>
    <deviceName>Hearing Loss Susceptibility HRM Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-HLS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:50.477Z</lastUpdated>
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    <basicUdiDi>B-06971532201576</basicUdiDi>
    <tradeName>06971532201576</tradeName>
    <deviceName>Hearing Loss Susceptibility GenoArray Diagnostic Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBGA-HLS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:49.769Z</lastUpdated>
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