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    <tradeName>AFIAS PSA Neo</tradeName>
    <deviceName>AFIAS PSA Neo</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:43:58.758Z</lastUpdated>
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    <udiDi>06973224897319</udiDi>
    <basicUdiDi>6973224890064AL</basicUdiDi>
    <tradeName>06973224897319</tradeName>
    <deviceName>iStar-Total PSA</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76092</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:08:21.154Z</lastUpdated>
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    <udiDi>06975984064314</udiDi>
    <basicUdiDi>69703416803205100HY</basicUdiDi>
    <tradeName>CA242 (eCLIA)</tradeName>
    <deviceName>CA242 (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:03:42.250Z</lastUpdated>
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    <udiDi>06950996003766</udiDi>
    <basicUdiDi>69509960FEPSA-402a-DRZB</basicUdiDi>
    <tradeName>06950996003766</tradeName>
    <deviceName>PSA Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEPSA-402a-DR10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:48:37.341Z</lastUpdated>
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    <udiDi>00816870022314</udiDi>
    <basicUdiDi>081687002PSAXS8775FK</basicUdiDi>
    <tradeName>PSA-XS AccuLite CLIA Kit - 96 Wells</tradeName>
    <deviceName>Total Prostate Specific Antigen Extra Sensitive (tPSA-XS) AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8775-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:18.142Z</lastUpdated>
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    <udiDi>00816870022277</udiDi>
    <basicUdiDi>081687002FPSA2375J8</basicUdiDi>
    <tradeName>Free PSA AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Free Prostate Specific Antigen (fPSA) AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2375-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:16.334Z</lastUpdated>
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    <udiDi>00816870022239</udiDi>
    <basicUdiDi>081687002CEANG4675LL</basicUdiDi>
    <tradeName>CEA NEXT GEN  AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Carcinoembryonic Antigen Next Generation (CEA-Next Generation) AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4675-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:12.345Z</lastUpdated>
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    <udiDi>00816870022178</udiDi>
    <basicUdiDi>081687002CA1535675S4</basicUdiDi>
    <tradeName>CA 15-3 AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Cancer Antigen 15-3 (CA 15-3) AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5675-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:10.744Z</lastUpdated>
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    <udiDi>00816870022154</udiDi>
    <basicUdiDi>081687002CA1253075Q7</basicUdiDi>
    <tradeName>CA-125 AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Cancer Antigen 125 (CA 125) AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3075-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:09.925Z</lastUpdated>
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    <udiDi>00816870022109</udiDi>
    <basicUdiDi>081687002PSAVAST84752H</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuLite VAST CLIA Kit - 192 wells</tradeName>
    <deviceName>Alpha-Fetoprotein,Carcinoembryonic Antigen and Total Prostate Specific Antigen (AFP/CEA/tPSA) VAST® AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030122</emdnCode>
    <emdnDescription>EARLY PROSTATE CANCER ANTIGEN - 2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8475-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:06.899Z</lastUpdated>
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    <udiDi>00816870020631</udiDi>
    <basicUdiDi>081687002PSAXS8725F4</basicUdiDi>
    <tradeName>PSA-XS AccuBind ELISA Kit - 96 Well</tradeName>
    <deviceName>Total Prostate Specific Antigen Extra Sensitive (tPSA-XS) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8725-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:05.137Z</lastUpdated>
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  <row>
    <udiDi>00816870020594</udiDi>
    <basicUdiDi>081687002FPSA2325HR</basicUdiDi>
    <tradeName>Free PSA AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Free Prostate Specific Antigen (fPSA) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2325-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:04.344Z</lastUpdated>
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    <udiDi>00816870020556</udiDi>
    <basicUdiDi>081687002CEANG4625L5</basicUdiDi>
    <tradeName>CEA NEXT GEN AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Carcinoembryonic Antigen Next Generation (CEA-Next Generation) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4625-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:03.528Z</lastUpdated>
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    <udiDi>00816870020518</udiDi>
    <basicUdiDi>081687002CA1993925VC</basicUdiDi>
    <tradeName>CA 19-9 AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Cancer Antigen 19-9 (CA 19-9) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3925-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:59.856Z</lastUpdated>
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    <udiDi>00816870020495</udiDi>
    <basicUdiDi>081687002CA1535625RM</basicUdiDi>
    <tradeName>CA 15-3 Accubind ELISA Kit - 96 wells</tradeName>
    <deviceName>Cancer Antigen 15-3 (CA 15-3) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5625-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:58.764Z</lastUpdated>
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    <udiDi>00816870020426</udiDi>
    <basicUdiDi>081687002PSAVAST842522</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuBind VAST ELISA Kit - 192 wells</tradeName>
    <deviceName>Alpha-Fetoprotein, Carcinoembryonic Antigen and Total Prostate Specific Antigen (AFP/CEA/tPSA) VAST® AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8425-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:57.127Z</lastUpdated>
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    <udiDi>06950996003773</udiDi>
    <basicUdiDi>69509960FEPSA-402a-DRZB</basicUdiDi>
    <tradeName>06950996003773</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEPSA-402a-DR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:57:09.565Z</lastUpdated>
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    <udiDi>06950996061162</udiDi>
    <basicUdiDi>69509960FEPSA-402a-DRZB</basicUdiDi>
    <tradeName>06950996061162</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEPSA-402a-DR10LH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:57:09.326Z</lastUpdated>
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    <basicUdiDi>69509960FEPSA-402a-DRZB</basicUdiDi>
    <tradeName>06950996064521</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEPSA-402a-DRLH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:57:09.297Z</lastUpdated>
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    <udiDi>00630414553344</udiDi>
    <basicUdiDi>0405686901812VR</basicUdiDi>
    <tradeName>ADVIA Centaur fPSA</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_Free Prostate-Specific Antigen</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10283414</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:27.191Z</lastUpdated>
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