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<eudamedExport entity="devices">
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    <basicUdiDi>69449040AB700000942</basicUdiDi>
    <tradeName>DCT DILUENT</tradeName>
    <deviceName>DCT DILUENT</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-020869-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:06.866Z</lastUpdated>
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  <row>
    <udiDi>06944413815827</udiDi>
    <basicUdiDi>69444138HematoryCon60DAJ</basicUdiDi>
    <tradeName>Hematology control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-60D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:41:42.176Z</lastUpdated>
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    <udiDi>06944413815773</udiDi>
    <basicUdiDi>69444138HematoryCon30DA3</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-30D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:41:41.126Z</lastUpdated>
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    <udiDi>06903053022712</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028629-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:36:42.682Z</lastUpdated>
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    <udiDi>06925794577993</udiDi>
    <basicUdiDi>69422022W010301010504R07Q</basicUdiDi>
    <tradeName>BF-SLS-I Lyse</tradeName>
    <deviceName>BF-SLS-I Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019948</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:59.936Z</lastUpdated>
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  <row>
    <udiDi>06925794577986</udiDi>
    <basicUdiDi>69422022W010301010513R07S</basicUdiDi>
    <tradeName>Lyse</tradeName>
    <deviceName>Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019915</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:57.542Z</lastUpdated>
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    <udiDi>06925794577948</udiDi>
    <basicUdiDi>69422022W010301010512R07M</basicUdiDi>
    <tradeName>BF-SLS-II Lyse</tradeName>
    <deviceName>BF-SLS-II Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019922</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:55.946Z</lastUpdated>
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    <udiDi>06925794577917</udiDi>
    <basicUdiDi>69422022W010301010508R08C</basicUdiDi>
    <tradeName>BF-FBH Lyse</tradeName>
    <deviceName>BF-FBH Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019905</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:55.448Z</lastUpdated>
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  <row>
    <udiDi>06925794577900</udiDi>
    <basicUdiDi>69422022W010301010505R07V</basicUdiDi>
    <tradeName>BF-FDOI Lyse</tradeName>
    <deviceName>BF-FDOI Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019957</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:55.431Z</lastUpdated>
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  <row>
    <udiDi>06925794577856</udiDi>
    <basicUdiDi>69422022W010301010506R082</basicUdiDi>
    <tradeName>BF-FDTI Lyse</tradeName>
    <deviceName>BF-FDTI Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019973</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:53.431Z</lastUpdated>
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  <row>
    <udiDi>06925794577849</udiDi>
    <basicUdiDi>69422022W010301010510R07B</basicUdiDi>
    <tradeName>BF-WFL Lyse</tradeName>
    <deviceName>BF-WFL Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019978</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:47.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794577818</udiDi>
    <basicUdiDi>69422022W010301010503R07K</basicUdiDi>
    <tradeName>BF-FDT Lyse</tradeName>
    <deviceName>BF-FDT Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019938</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:46.226Z</lastUpdated>
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    <udiDi>06925794577764</udiDi>
    <basicUdiDi>69422022W010301010511R07G</basicUdiDi>
    <tradeName>BF-WNL Lyse</tradeName>
    <deviceName>BF-WNL Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019960</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:45.434Z</lastUpdated>
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    <udiDi>06925794577757</udiDi>
    <basicUdiDi>69422022W010301010509R08H</basicUdiDi>
    <tradeName>BF-CRP Lyse</tradeName>
    <deviceName>BF-CRP Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019904</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:41.429Z</lastUpdated>
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    <udiDi>06925794577726</udiDi>
    <basicUdiDi>69422022W010301010507R087</basicUdiDi>
    <tradeName>BCC-3D Lyse</tradeName>
    <deviceName>BCC-3D Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019949</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:40.633Z</lastUpdated>
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    <udiDi>06925794577603</udiDi>
    <basicUdiDi>69422022W010301010501R079</basicUdiDi>
    <tradeName>Lyse</tradeName>
    <deviceName>Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019937</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:40.138Z</lastUpdated>
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    <udiDi>06936895302766</udiDi>
    <basicUdiDi>69368953HAL132R5</basicUdiDi>
    <tradeName>Hematology Analyzer Lyse</tradeName>
    <deviceName>Hematology Analyzer Lyse</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFL 500mL（10103）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:00:44.728Z</lastUpdated>
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    <udiDi>06936895302759</udiDi>
    <basicUdiDi>69368953HAD133PF</basicUdiDi>
    <tradeName>Hematology Analyzer Diluent</tradeName>
    <deviceName>Hematology Analyzer Diluent</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10×SFL-1 2L（10106）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:00:43.079Z</lastUpdated>
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    <udiDi>06934175046249</udiDi>
    <basicUdiDi>6934175002B0030NY</basicUdiDi>
    <tradeName>Hematology Reagent Kit</tradeName>
    <deviceName>Hematology Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12600777</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:11.739Z</lastUpdated>
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    <udiDi>06934175010288</udiDi>
    <basicUdiDi>6934175002A0001NE</basicUdiDi>
    <tradeName>06934175010288</tradeName>
    <deviceName>Portable Automatic Multi-function Analyzer</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3V001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:04.533Z</lastUpdated>
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