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    <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>06974689627251</udiDi>
    <basicUdiDi>B-06974689627251</basicUdiDi>
    <tradeName>Chromosomal aneuploidies digital PCR detection kit</tradeName>
    <deviceName>Chromosomal aneuploidies 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>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:43.476Z</lastUpdated>
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    <udiDi>06974689627244</udiDi>
    <basicUdiDi>B-06974689627244</basicUdiDi>
    <tradeName>Chromosomal aneuploidies digital PCR detection kit</tradeName>
    <deviceName>Chromosomal aneuploidies 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>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13308-3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:42.677Z</lastUpdated>
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    <udiDi>06974689627237</udiDi>
    <basicUdiDi>B-06974689627237</basicUdiDi>
    <tradeName>Chromosomal aneuploidies digital PCR detection kit</tradeName>
    <deviceName>Chromosomal aneuploidies 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>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13308-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:41.980Z</lastUpdated>
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    <udiDi>06974689627091</udiDi>
    <basicUdiDi>B-06974689627091</basicUdiDi>
    <tradeName>Spinal muscular atrophy (SMA) digital PCR detection kit</tradeName>
    <deviceName>Spinal muscular atrophy (SMA) 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13203-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:16.266Z</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>06974689626612</udiDi>
    <basicUdiDi>B-06974689626612</basicUdiDi>
    <tradeName>MELAS genetic mutation digital PCR detection kit</tradeName>
    <deviceName>MELAS genetic mutation 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13309-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:13.749Z</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>06974689626520</udiDi>
    <basicUdiDi>B-06974689626520</basicUdiDi>
    <tradeName>Chromosomal aneuploidies digital PCR detection kit</tradeName>
    <deviceName>Chromosomal aneuploidies 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>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13308-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:36.584Z</lastUpdated>
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    <udiDi>06974689626100</udiDi>
    <basicUdiDi>B-06974689626100</basicUdiDi>
    <tradeName>Spinal muscular atrophy (SMA) digital PCR detection kit</tradeName>
    <deviceName>Spinal muscular atrophy (SMA) 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13203-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:11.765Z</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>06974674892572</udiDi>
    <basicUdiDi>B-06974674892572</basicUdiDi>
    <tradeName>Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:31.826Z</lastUpdated>
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    <udiDi>06974674892565</udiDi>
    <basicUdiDi>B-06974674892565</basicUdiDi>
    <tradeName>Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:31.018Z</lastUpdated>
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    <udiDi>06974604726847</udiDi>
    <basicUdiDi>B-06974604726847</basicUdiDi>
    <tradeName>06974604726847</tradeName>
    <deviceName>SHOX Gene Deletion Probe Detection Kit (fluorescence in situ hybridization)</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>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZY-ISH-P227A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:06:17.426Z</lastUpdated>
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    <udiDi>06974604726830</udiDi>
    <basicUdiDi>B-06974604726830</basicUdiDi>
    <tradeName>06974604726830</tradeName>
    <deviceName>Gene Probe Kit for DiGeorge Syndrome (fluorescence in situ hybridization)</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>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZY-ISH-P223A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:06:13.421Z</lastUpdated>
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    <udiDi>06974604726809</udiDi>
    <basicUdiDi>B-06974604726809</basicUdiDi>
    <tradeName>06974604726809</tradeName>
    <deviceName>Chromosome X/Y Probe Detection Kit (fluorescence in situ hybridization)</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>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZY-ISH-P230A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:06:11.035Z</lastUpdated>
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    <udiDi>06974604720210</udiDi>
    <basicUdiDi>B-06974604720210</basicUdiDi>
    <tradeName>06974604720210</tradeName>
    <deviceName>Human Leukocyte B site 5801 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>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZYMT-039-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:01:21.942Z</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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