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<eudamedExport entity="devices">
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    <basicUdiDi>019030244107169T</basicUdiDi>
    <tradeName>Septa Cathode Buffer Container Dx</tradeName>
    <deviceName>Septa Cathode Buffer Container, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4410716</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:13.301Z</lastUpdated>
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  <row>
    <udiDi>10190302000260</udiDi>
    <basicUdiDi>019030244107009C</basicUdiDi>
    <tradeName>96-Well Septa Dx</tradeName>
    <deviceName>96-Well Septa, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4410700</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:10.902Z</lastUpdated>
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  <row>
    <udiDi>10190302000253</udiDi>
    <basicUdiDi>0190302441022797</basicUdiDi>
    <tradeName>3500 Dx Series 96-Well Standard Retainer &amp; Base Set</tradeName>
    <deviceName>96-Well/384-Well Standard Retainer and Base Set, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4410227</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:09.306Z</lastUpdated>
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  <row>
    <udiDi>10190302000246</udiDi>
    <basicUdiDi>01903024409543B8</basicUdiDi>
    <tradeName>Conditioning Reagent Dx</tradeName>
    <deviceName>Conditioning Reagent, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4409543</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:08.506Z</lastUpdated>
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  <row>
    <udiDi>10190302000208</udiDi>
    <basicUdiDi>01903024404682AL</basicUdiDi>
    <tradeName>3500 Dx Capillary Array 50-cm</tradeName>
    <deviceName>Capillary Array 36-cm/50-cm, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4404684</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:06.903Z</lastUpdated>
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  <row>
    <udiDi>10190302000192</udiDi>
    <basicUdiDi>019030244043079P</basicUdiDi>
    <tradeName>Hi-Di™ Formamide Dx (5 mL)</tradeName>
    <deviceName>Hi-Di™ Formamide, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4404307 (4440752)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:04.496Z</lastUpdated>
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  <row>
    <udiDi>10190302000185</udiDi>
    <basicUdiDi>01903024408258AX</basicUdiDi>
    <tradeName>Anode Buffer Container Dx</tradeName>
    <deviceName>Buffer Container, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4393925</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:02.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302000147</udiDi>
    <basicUdiDi>01903024393709CW</basicUdiDi>
    <tradeName>POP-7™ Polymer Dx (384 Samples)</tradeName>
    <deviceName>POP™ polymer, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4393709</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:02.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840733102332</udiDi>
    <basicUdiDi>008407331REVOGENECLA003TK</basicUdiDi>
    <tradeName>Revogene® Mock Pie</tradeName>
    <deviceName>Revogene® Mock Pie</deviceName>
    <manufacturerName>Meridian Bioscience Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044096</manufacturerSrn>
    <authorisedRepresentativeName>Meridian Bioscience Europe S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000010460</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610208</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:25:04.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840733102318</udiDi>
    <basicUdiDi>008407331REVOGENECLA001TF</basicUdiDi>
    <tradeName>Revogene®</tradeName>
    <deviceName>Revogene®</deviceName>
    <manufacturerName>Meridian Bioscience Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044096</manufacturerSrn>
    <authorisedRepresentativeName>Meridian Bioscience Europe S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000010460</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:25:03.944Z</lastUpdated>
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  <row>
    <udiDi>00840733101663</udiDi>
    <basicUdiDi>008407331ALETHIACLA001QV</basicUdiDi>
    <tradeName>Alethia</tradeName>
    <deviceName>Alethia</deviceName>
    <manufacturerName>Meridian Bioscience Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044096</manufacturerSrn>
    <authorisedRepresentativeName>Meridian Bioscience Europe S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000010460</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610189</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:24:50.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816270020125</udiDi>
    <basicUdiDi>0081627002NEXTSEQAD</basicUdiDi>
    <tradeName>NextSeq™ 550Dx Instrument</tradeName>
    <deviceName>NextSeq™ 550Dx Instrument</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20005715</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:37.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816270020002</udiDi>
    <basicUdiDi>0081627002MISEQQP</basicUdiDi>
    <tradeName>MiSeq™Dx Instrument</tradeName>
    <deviceName>MiSeq™Dx Instrument</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX-410-1001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:36.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>G763I190007TM0</udiDi>
    <basicUdiDi>++G763I190007TM3C</basicUdiDi>
    <tradeName>SAMBA III Tablet Module</tradeName>
    <deviceName>SAMBA III Tablet Module</deviceName>
    <manufacturerName>Diagnostics for the Real World (Europe) Ltd.</manufacturerName>
    <manufacturerSrn>UK-MF-000047660</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I190007TM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:35:39.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G763I190007AM0</udiDi>
    <basicUdiDi>++G763I190007AMZG</basicUdiDi>
    <tradeName>SAMBA III Assay Module</tradeName>
    <deviceName>SAMBA III Assay Module</deviceName>
    <manufacturerName>Diagnostics for the Real World (Europe) Ltd.</manufacturerName>
    <manufacturerSrn>UK-MF-000047660</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I190007AM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:30:22.749Z</lastUpdated>
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    <udiDi>Not_app</udiDi>
    <basicUdiDi>++G143TC8ReactionTubeWS</basicUdiDi>
    <tradeName>T-COR 8 Reaction Tube</tradeName>
    <deviceName>T-COR 8 Reaction Tube</deviceName>
    <manufacturerName>Tetracore INC</manufacturerName>
    <manufacturerSrn>US-MF-000023064</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC-5029-500</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:39:28.811Z</lastUpdated>
  </row>
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    <udiDi>None</udiDi>
    <basicUdiDi>++G143TC8MagneticMixerY5</basicUdiDi>
    <tradeName>T-COR 8 Magnetic Mixer</tradeName>
    <deviceName>T-COR 8 Magnetic Mixer</deviceName>
    <manufacturerName>Tetracore INC</manufacturerName>
    <manufacturerSrn>US-MF-000023064</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC-5018-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:39:28.019Z</lastUpdated>
  </row>
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    <udiDi>NA</udiDi>
    <basicUdiDi>++G143TC8RTPCRInstKF</basicUdiDi>
    <tradeName>T-COR 8</tradeName>
    <deviceName>T-COR 8</deviceName>
    <manufacturerName>Tetracore INC</manufacturerName>
    <manufacturerSrn>US-MF-000023064</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC-5049-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:39:26.410Z</lastUpdated>
  </row>
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    <udiDi>EVIRVCNUPR1</udiDi>
    <basicUdiDi>++EVIRSoftware98</basicUdiDi>
    <tradeName>ViraChip Software</tradeName>
    <deviceName>Software</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050292</emdnCode>
    <emdnDescription>MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-VCNUPR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:33.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EVIRUVCSCA1</udiDi>
    <basicUdiDi>++EVIRLaboratoryDeviceFP</basicUdiDi>
    <tradeName>ViraChip Scanner</tradeName>
    <deviceName>Laboratory Device</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050107</emdnCode>
    <emdnDescription>MICRO-ARRAY SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-UVCSCA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:21:37.131Z</lastUpdated>
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