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    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 1-7ml/h Bolus 2ml Refill 15 min Single NRFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487230N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.441Z</lastUpdated>
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    <udiDi>18859299112661</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 1-7ml/h Bolus 2ml Refill 15 min Bifurcate NRFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487240N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.412Z</lastUpdated>
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    <udiDi>18859299112678</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 60 min Single NRFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487250N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.381Z</lastUpdated>
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    <udiDi>18859299112685</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 1ml Refill 15 min Single NRFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487260N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.339Z</lastUpdated>
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    <udiDi>18859299112692</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 15 min Single NRFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487270N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.308Z</lastUpdated>
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    <udiDi>18859299112708</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 15 min Bifurcate Hanger Cap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487280N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.256Z</lastUpdated>
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    <udiDi>18859299129027</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Pump 120-10-12h</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>480257</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:07.448Z</lastUpdated>
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    <udiDi>18859299129034</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Pump 100-200-30m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>481017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:07.402Z</lastUpdated>
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    <udiDi>06938016775602</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016775602</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6522-R02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.283Z</lastUpdated>
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    <udiDi>06938016775770</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016775770</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.256Z</lastUpdated>
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    <udiDi>06938016775787</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016775787</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6522-0R05</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.240Z</lastUpdated>
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    <udiDi>06938016776135</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016776135</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-S2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.035Z</lastUpdated>
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    <udiDi>06938016776142</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016776142</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-5</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.015Z</lastUpdated>
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    <udiDi>06938016776159</udiDi>
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    <tradeName>06938016776159</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-07</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.990Z</lastUpdated>
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    <udiDi>06938016780064</udiDi>
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    <tradeName>06938016780064</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.785Z</lastUpdated>
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    <udiDi>06938016780095</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6522-06</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.765Z</lastUpdated>
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    <udiDi>06938016780101</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-05</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.745Z</lastUpdated>
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    <udiDi>06938119319703</udiDi>
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    <tradeName>06938119319703</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCBI27515L50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:06.902Z</lastUpdated>
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    <tradeName>06938119322413</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCBI20020L50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:06.875Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCBI06010L50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:06.818Z</lastUpdated>
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