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    <tradeName>Cyclosporine A CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cyclosporine A CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11409</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:29:16.117Z</lastUpdated>
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    <tradeName>Trastuzumab CLIA kit (Chemiluminescence Immunoassay)W01020899</tradeName>
    <deviceName>Trastuzumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11439</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:28:44.908Z</lastUpdated>
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    <tradeName>Anti-vedolizumab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Anti-vedolizumab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11426</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:27:17.729Z</lastUpdated>
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    <basicUdiDi>697518250P1142166</basicUdiDi>
    <tradeName>Vedolizumab Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Vedolizumab Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11421</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:27:11.581Z</lastUpdated>
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    <udiDi>06942293581894</udiDi>
    <basicUdiDi>697518250P114276J</basicUdiDi>
    <tradeName>Anti-ustekinumab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Anti-ustekinumab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11427</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:27:10.422Z</lastUpdated>
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    <udiDi>06942293581887</udiDi>
    <basicUdiDi>697518250P1142268</basicUdiDi>
    <tradeName>Ustekinumab Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Ustekinumab Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:27:08.835Z</lastUpdated>
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    <udiDi>06942293581870</udiDi>
    <basicUdiDi>697518250P1143067</basicUdiDi>
    <tradeName>Anti-golimumab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Anti-golimumab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11430</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:27:07.937Z</lastUpdated>
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    <basicUdiDi>697518250P114256E</basicUdiDi>
    <tradeName>Golimumab Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Golimumab Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11425</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:27:01.877Z</lastUpdated>
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    <udiDi>06942293581634</udiDi>
    <basicUdiDi>697518250G127273K</basicUdiDi>
    <tradeName>Gabapentin Panel Test Drugs of Abuse Test Kit</tradeName>
    <deviceName>Gabapentin Panel Test Drugs of Abuse Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080211</emdnCode>
    <emdnDescription>GABAPENTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G12727</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:14.048Z</lastUpdated>
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    <udiDi>06942293581375</udiDi>
    <basicUdiDi>697518250P114286L</basicUdiDi>
    <tradeName>Anti-infliximab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Anti-infliximab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11428</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:25:22.325Z</lastUpdated>
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    <udiDi>06942293581368</udiDi>
    <basicUdiDi>697518250P114296N</basicUdiDi>
    <tradeName>Anti-adalimumab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Anti-adalimumab Antibody Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080799</emdnCode>
    <emdnDescription>AUTOIMMUNE DISEASE TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11429</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:25:16.215Z</lastUpdated>
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    <udiDi>06942293581306</udiDi>
    <basicUdiDi>697518250P114236A</basicUdiDi>
    <tradeName>Infliximab  Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Infliximab  Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11423</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:25:14.755Z</lastUpdated>
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    <basicUdiDi>697518250P114246C</basicUdiDi>
    <tradeName>Adalimumab Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Adalimumab Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11424</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:25:13.924Z</lastUpdated>
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    <udiDi>06942293581139</udiDi>
    <basicUdiDi>697518250P114176F</basicUdiDi>
    <tradeName>Rifampicin Determination Kit（Fluorescence Immunochromatographic Assay）</tradeName>
    <deviceName>Rifampicin Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11417</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:54.352Z</lastUpdated>
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    <basicUdiDi>697518250P114186H</basicUdiDi>
    <tradeName>Isoniazid Determination Kit（Fluorescence Immunochromatographic Assay）</tradeName>
    <deviceName>Isoniazid Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11418</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:53.526Z</lastUpdated>
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    <basicUdiDi>697518250P114096G</basicUdiDi>
    <tradeName>Cyclosporine A Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Cyclosporine A Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11409</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:47.416Z</lastUpdated>
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    <basicUdiDi>697518250P114156B</basicUdiDi>
    <tradeName>5-Fluorouracil Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>5-Fluorouracil Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11415</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:23.143Z</lastUpdated>
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    <basicUdiDi>697518250P1140262</basicUdiDi>
    <tradeName>Theophylline Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Theophylline Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080402</emdnCode>
    <emdnDescription>THEOPHYLLINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:23:42.718Z</lastUpdated>
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    <basicUdiDi>697518250P114086E</basicUdiDi>
    <tradeName>Phenytoin Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Phenytoin Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11408</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:23:41.131Z</lastUpdated>
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    <basicUdiDi>697518250P114105Z</basicUdiDi>
    <tradeName>Tacrolimus Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Tacrolimus Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11421</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:23:30.502Z</lastUpdated>
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