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    <udiDi>06974689626629</udiDi>
    <basicUdiDi>B-06974689626629</basicUdiDi>
    <tradeName>ESR1 mutation digital PCR detection kit</tradeName>
    <deviceName>ESR1 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12644-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:18.548Z</lastUpdated>
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    <udiDi>06974689626605</udiDi>
    <basicUdiDi>B-06974689626605</basicUdiDi>
    <tradeName>Craniopharyngioma-associated gene muation digital PCR detection kit</tradeName>
    <deviceName>Craniopharyngioma-associated gene muation 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12914-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:12.946Z</lastUpdated>
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    <udiDi>06974689626599</udiDi>
    <basicUdiDi>B-06974689626599</basicUdiDi>
    <tradeName>Lung cancer-associated gene mutation digital PCR detection kit</tradeName>
    <deviceName>Lung cancer-associated gene 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12699-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:12.164Z</lastUpdated>
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    <udiDi>06974689626582</udiDi>
    <basicUdiDi>B-06974689626582</basicUdiDi>
    <tradeName>KRAS mutation digital PCR detection kit</tradeName>
    <deviceName>KRAS 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>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12541-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:11.348Z</lastUpdated>
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    <udiDi>06974689626575</udiDi>
    <basicUdiDi>B-06974689626575</basicUdiDi>
    <tradeName>Breast cancer–associated gene mutation digital PCR detection kit</tradeName>
    <deviceName>Breast cancer–associated gene 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12696-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:55.869Z</lastUpdated>
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    <udiDi>06974689626230</udiDi>
    <basicUdiDi>B-06974689626230</basicUdiDi>
    <tradeName>Lung cancer digital PCR panel</tradeName>
    <deviceName>Lung cancer digital PCR panel</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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12682-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:25.375Z</lastUpdated>
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    <udiDi>06974689626223</udiDi>
    <basicUdiDi>B-06974689626223</basicUdiDi>
    <tradeName>Lung cancer digital PCR panel plus</tradeName>
    <deviceName>Lung cancer digital PCR panel plus</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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12683-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:24.570Z</lastUpdated>
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  <row>
    <udiDi>06974689626216</udiDi>
    <basicUdiDi>B-06974689626216</basicUdiDi>
    <tradeName>HER2 amplification digital PCR detection kit</tradeName>
    <deviceName>HER2 amplification 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>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12633-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:23.774Z</lastUpdated>
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  <row>
    <udiDi>06974689626209</udiDi>
    <basicUdiDi>B-06974689626209</basicUdiDi>
    <tradeName>FGFR gene fusions and mutation digital PCR detection kit</tradeName>
    <deviceName>FGFR gene fusions and mutation 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>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12585-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:22.971Z</lastUpdated>
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  <row>
    <udiDi>06974689626131</udiDi>
    <basicUdiDi>B-06974689626131</basicUdiDi>
    <tradeName>ALK/ROS1/MET gene fusions and mutations digital PCR detection kit</tradeName>
    <deviceName>ALK/ROS1/MET gene fusions and mutations 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12605-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:17.372Z</lastUpdated>
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  <row>
    <udiDi>06974689626124</udiDi>
    <basicUdiDi>B-06974689626124</basicUdiDi>
    <tradeName>TERT/BRAF mutations digital PCR detection kit</tradeName>
    <deviceName>TERT/BRAF mutations 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>W01060212</emdnCode>
    <emdnDescription>TELOMERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12621-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:16.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689626117</udiDi>
    <basicUdiDi>B-06974689626117</basicUdiDi>
    <tradeName>Thyroid carcinoma digital PCR panel</tradeName>
    <deviceName>Thyroid carcinoma digital PCR panel</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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12691-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:15.772Z</lastUpdated>
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  <row>
    <udiDi>06974689626094</udiDi>
    <basicUdiDi>B-06974689626094</basicUdiDi>
    <tradeName>PIK3CA mutation digital PCR detection kit</tradeName>
    <deviceName>PIK3CA mutation 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12545-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:10.991Z</lastUpdated>
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    <udiDi>06974689626087</udiDi>
    <basicUdiDi>B-06974689626087</basicUdiDi>
    <tradeName>BCR-ABL p210 digital PCR detection kit</tradeName>
    <deviceName>BCR-ABL p210 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>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12901-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:10.164Z</lastUpdated>
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    <udiDi>06974689626063</udiDi>
    <basicUdiDi>B-06974689626063</basicUdiDi>
    <tradeName>KRAS/BRAF/NRAS/PIK3CA mutations digital PCR detection kit</tradeName>
    <deviceName>KRAS/BRAF/NRAS/PIK3CA mutations 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>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12608-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:04.576Z</lastUpdated>
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    <udiDi>06974689626049</udiDi>
    <basicUdiDi>B-06974689626049</basicUdiDi>
    <tradeName>EGFR mutations digital PCR detection kit</tradeName>
    <deviceName>EGFR mutations 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12517-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:02.965Z</lastUpdated>
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    <udiDi>06974689626032</udiDi>
    <basicUdiDi>B-06974689626032</basicUdiDi>
    <tradeName>EGFR Ex19Del/L858R/T790M mutations digital PCR detection kit</tradeName>
    <deviceName>EGFR Ex19Del/L858R/T790M mutations 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12507-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:02.176Z</lastUpdated>
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    <udiDi>06974689626025</udiDi>
    <basicUdiDi>B-06974689626025</basicUdiDi>
    <tradeName>Colorectal cancer methylation digital PCR panel</tradeName>
    <deviceName>Colorectal cancer methylation digital PCR panel</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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12693-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:23:57.384Z</lastUpdated>
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    <udiDi>06974604726878</udiDi>
    <basicUdiDi>B-06974604726878</basicUdiDi>
    <tradeName>06974604726878</tradeName>
    <deviceName>7q11.23 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZY-ISH-P221A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:06:20.635Z</lastUpdated>
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    <udiDi>06974604726861</udiDi>
    <basicUdiDi>B-06974604726861</basicUdiDi>
    <tradeName>06974604726861</tradeName>
    <deviceName>5q 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZY-ISH-P220A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:06:19.837Z</lastUpdated>
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