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    <tradeName>Biossays Immunoglobulin G (Latex Immunoturbidimetric)</tradeName>
    <deviceName>Immunoglobulin G (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130503012S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:40.358Z</lastUpdated>
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    <udiDi>06947145551322</udiDi>
    <basicUdiDi>69471455569X4</basicUdiDi>
    <tradeName>Biossays Lambda Light Chain (Immunoturbidimetric)</tradeName>
    <deviceName>Lambda Light Chain (Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130508017S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:29.143Z</lastUpdated>
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    <udiDi>06947145551087</udiDi>
    <basicUdiDi>69471455568X2</basicUdiDi>
    <tradeName>Biossays Kappa Light Chain (Immunoturbidimetric)</tradeName>
    <deviceName>Kappa Light Chain (Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130508016S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:27.539Z</lastUpdated>
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    <udiDi>00630414312439</udiDi>
    <basicUdiDi>0405686902230V4</basicUdiDi>
    <tradeName>N Latex FLC lambda</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_N_La_FLC_2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873768</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:54.104Z</lastUpdated>
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  <row>
    <udiDi>00842768030048</udiDi>
    <basicUdiDi>0405686901307V7</basicUdiDi>
    <tradeName>Emit 2000 Siro/Tacro Sample Pretreatment Reagent</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Siro.Tacro Sample Pretreatment Reag</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10488260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:49.617Z</lastUpdated>
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    <udiDi>00630414972879</udiDi>
    <basicUdiDi>0405686901345VF</basicUdiDi>
    <tradeName>IMMULITE 2000 Multi-Diluent 2</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_Multi-Diluent 2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387058</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:57.643Z</lastUpdated>
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    <udiDi>00630414954318</udiDi>
    <basicUdiDi>0405686901355VJ</basicUdiDi>
    <tradeName>IMMULITE 2000 Thyroglobulin Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_Thyroglobulin Sample Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387073</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:32.523Z</lastUpdated>
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    <udiDi>00630414954103</udiDi>
    <basicUdiDi>0405686901346VH</basicUdiDi>
    <tradeName>IMMULITE 2000 NT-ProBNP Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_NT-ProBNP Sample Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:30.312Z</lastUpdated>
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    <udiDi>00630414954073</udiDi>
    <basicUdiDi>0405686901343VB</basicUdiDi>
    <tradeName>IMMULITE 2000 Multi-Diluent 1</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_Multi-Diluent 1</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:28.627Z</lastUpdated>
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  <row>
    <udiDi>00630414595771</udiDi>
    <basicUdiDi>0405686901556VW</basicUdiDi>
    <tradeName>Atellica CH Diluent</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:07.668Z</lastUpdated>
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    <udiDi>00630414443010</udiDi>
    <basicUdiDi>0405686901587W9</basicUdiDi>
    <tradeName>ADVIA Centaur VB12 DTT / Releasing Agent</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_VB12 DTT / Releasing Agent</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10310330</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:23:40.439Z</lastUpdated>
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    <udiDi>00842768008467</udiDi>
    <basicUdiDi>0405686900985WJ</basicUdiDi>
    <tradeName>N AS IgG2</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_AS_IGG2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446169</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:54.348Z</lastUpdated>
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    <udiDi>00842768008450</udiDi>
    <basicUdiDi>0405686900984WG</basicUdiDi>
    <tradeName>N AS IgG1</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_AS_IGG1</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446168</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:53.552Z</lastUpdated>
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    <udiDi>00842768007200</udiDi>
    <basicUdiDi>0405686900958WF</basicUdiDi>
    <tradeName>N Latex IgA</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT_N_La_IGA</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:37.225Z</lastUpdated>
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    <udiDi>00842768007194</udiDi>
    <basicUdiDi>0405686900960W2</basicUdiDi>
    <tradeName>N Latex IgM</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT_N_La_IGM</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:18.219Z</lastUpdated>
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    <udiDi>00842768006708</udiDi>
    <basicUdiDi>0405686900883W9</basicUdiDi>
    <tradeName>N Latex IgG3</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_La_IGG3</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445972</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:07.807Z</lastUpdated>
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    <udiDi>00842768006692</udiDi>
    <basicUdiDi>0405686900884WB</basicUdiDi>
    <tradeName>N Latex IgG4</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_La_IGG4</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445971</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:07.010Z</lastUpdated>
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    <udiDi>00842768006166</udiDi>
    <basicUdiDi>0405686900917VZ</basicUdiDi>
    <tradeName>Dimension Vista Immunoglobulin A Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_MAR EB_C_KIT_V_IGA</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:18:50.288Z</lastUpdated>
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    <udiDi>00842768009815</udiDi>
    <basicUdiDi>0405686900180UY</basicUdiDi>
    <tradeName>N Antiserum to Human IgM</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_N_AS_IGM</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:11.452Z</lastUpdated>
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    <udiDi>00842768009778</udiDi>
    <basicUdiDi>0405686900179VF</basicUdiDi>
    <tradeName>N Antiserum to Human IgG</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_N_AS_IGG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446296</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:08.533Z</lastUpdated>
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