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    <basicUdiDi>B-08436589880153</basicUdiDi>
    <tradeName>Imegen-Quimera Q116-6I dPCR Dry</tradeName>
    <deviceName>Imegen-Quimera Q116-6I dPCR Dry</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-116-32 Dry</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:48:19.948Z</lastUpdated>
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    <udiDi>08436589880092</udiDi>
    <basicUdiDi>B-08436589880092</basicUdiDi>
    <tradeName>Imegen-Quimera Q116-3I dPCR Dry</tradeName>
    <deviceName>Imegen-Quimera Q116-3I dPCR Dry</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-116-29 Dry</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:48:18.673Z</lastUpdated>
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    <udiDi>08436589880139</udiDi>
    <basicUdiDi>B-08436589880139</basicUdiDi>
    <tradeName>Imegen-Quimera Q116-5I dPCR Dry</tradeName>
    <deviceName>Imegen-Quimera Q116-5I dPCR Dry</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-116-31 Dry</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:48:17.005Z</lastUpdated>
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    <udiDi>08436589880115</udiDi>
    <basicUdiDi>B-08436589880115</basicUdiDi>
    <tradeName>Imegen-Quimera Q116-4I dPCR Dry</tradeName>
    <deviceName>Imegen-Quimera Q116-4I dPCR Dry</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-116-30 Dry</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:48:15.199Z</lastUpdated>
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  <row>
    <udiDi>08436589880078</udiDi>
    <basicUdiDi>B-08436589880078</basicUdiDi>
    <tradeName>Imegen-Quimera RhD dPCR Dry</tradeName>
    <deviceName>Imegen-Quimera RhD dPCR Dry</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-116-28 Dry</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:48:13.601Z</lastUpdated>
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  <row>
    <udiDi>08436589880054</udiDi>
    <basicUdiDi>B-08436589880054</basicUdiDi>
    <tradeName>Imegen-Quimera SRY dPCR Dry</tradeName>
    <deviceName>Imegen-Quimera SRY dPCR Dry</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-116-27 Dry</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:48:12.128Z</lastUpdated>
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  <row>
    <udiDi>08436589880030</udiDi>
    <basicUdiDi>B-08436589880030</basicUdiDi>
    <tradeName>Imegen-Quimera Screening Multiplex Plus</tradeName>
    <deviceName>Imegen-Quimera Screening Multiplex Plus</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-116-26</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:48:08.785Z</lastUpdated>
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  <row>
    <udiDi>08436589880023</udiDi>
    <basicUdiDi>B-08436589880023</basicUdiDi>
    <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>08057680910695</udiDi>
    <basicUdiDi>B-08057680910695</basicUdiDi>
    <tradeName>Gluten DQuick DResolution</tradeName>
    <deviceName>Gluten DQuick DResolution</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-59v3_96</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:20.492Z</lastUpdated>
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    <udiDi>08057680910688</udiDi>
    <basicUdiDi>B-08057680910688</basicUdiDi>
    <tradeName>Gluten DQuick Dresolution</tradeName>
    <deviceName>Gluten DQuick DResolution</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-59v3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:19.706Z</lastUpdated>
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    <udiDi>08057680910442</udiDi>
    <basicUdiDi>B-08057680910442</basicUdiDi>
    <tradeName>Duplicα Real Time HLA-B*5701 EZ Type Kit</tradeName>
    <deviceName>Duplicα Real Time HLA-B*5701 EZ Type Kit</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EER052032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:33:29.303Z</lastUpdated>
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    <udiDi>08057680910329</udiDi>
    <basicUdiDi>B-08057680910329</basicUdiDi>
    <tradeName>HLA-B27</tradeName>
    <deviceName>HLA-B27</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-53</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:33:28.500Z</lastUpdated>
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  <row>
    <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>
    <reference>480 tests/kit</reference>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 tests/kit</reference>
    <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>06974858560174</udiDi>
    <basicUdiDi>B-06974858560174</basicUdiDi>
    <tradeName>06974858560174</tradeName>
    <deviceName>Human Leukocyte Antigen B27 Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P118H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:58:08.025Z</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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