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    <tradeName>06974795550436</tradeName>
    <deviceName>Five Infectious Diarrhea Bacteria Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10200159B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:44:13.769Z</lastUpdated>
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    <udiDi>06974795550429</udiDi>
    <basicUdiDi>B-06974795550429</basicUdiDi>
    <tradeName>06974795550429</tradeName>
    <deviceName>Five Infectious Diarrhea Bacteria Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>06974795550412</udiDi>
    <basicUdiDi>B-06974795550412</basicUdiDi>
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    <deviceName>Diarrhea Related Pathogen Nucleic Acid Detection Kit（PCR-Fluorescent Probe Method）</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>06974795550405</udiDi>
    <basicUdiDi>B-06974795550405</basicUdiDi>
    <tradeName>06974795550405</tradeName>
    <deviceName>Diarrhea Related Pathogen Nucleic Acid Detection Kit（PCR-Fluorescent Probe Method）</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210113A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:44:11.356Z</lastUpdated>
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    <udiDi>06974323013099</udiDi>
    <basicUdiDi>B-06974323013099</basicUdiDi>
    <tradeName>06974323013099</tradeName>
    <deviceName>Multiplex PCR Diagnostic Kit for Rapid Detection of Five Genera of Diarrheogenic E. coli (GB.V.)(Freeze-dried Type)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A3943FD-48T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:34.594Z</lastUpdated>
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    <udiDi>06974323013082</udiDi>
    <basicUdiDi>B-06974323013082</basicUdiDi>
    <tradeName>06974323013082</tradeName>
    <deviceName>Multiplex PCR Diagnostic Kit for Rapid Detection of Five Genera of Diarrheogenic E. coli (GB.V.)(Freeze-dried Type)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A3943FD-24T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:33.806Z</lastUpdated>
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    <udiDi>06974323013075</udiDi>
    <basicUdiDi>B-06974323013075</basicUdiDi>
    <tradeName>06974323013075</tradeName>
    <deviceName>Multiplex PCR Detection Kit for 5 Diarrheagenic Escherichia coli</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A211LFD-48T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:33.011Z</lastUpdated>
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    <udiDi>06974323013068</udiDi>
    <basicUdiDi>B-06974323013068</basicUdiDi>
    <tradeName>06974323013068</tradeName>
    <deviceName>Multiplex PCR Detection Kit for 5 Diarrheagenic Escherichia coli</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A211LFD-24T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:32.201Z</lastUpdated>
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    <udiDi>06974323012498</udiDi>
    <basicUdiDi>B-06974323012498</basicUdiDi>
    <tradeName>06974323012498</tradeName>
    <deviceName>Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A9106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:29.660Z</lastUpdated>
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    <udiDi>06974323012481</udiDi>
    <basicUdiDi>B-06974323012481</basicUdiDi>
    <tradeName>06974323012481</tradeName>
    <deviceName>Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A9106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:28.062Z</lastUpdated>
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    <udiDi>06974323011545</udiDi>
    <basicUdiDi>B-06974323011545</basicUdiDi>
    <tradeName>06974323011545</tradeName>
    <deviceName>Triplex Real-Time PCR Kit for Detection of Norovirus, Rotavirus and Adenovirus</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:48.638Z</lastUpdated>
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    <udiDi>06974323011538</udiDi>
    <basicUdiDi>B-06974323011538</basicUdiDi>
    <tradeName>06974323011538</tradeName>
    <deviceName>Triplex Real-Time PCR Kit for Detection of Norovirus, Rotavirus and Adenovirus</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:47.836Z</lastUpdated>
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    <udiDi>06974323011361</udiDi>
    <basicUdiDi>B-06974323011361</basicUdiDi>
    <tradeName>06974323011361</tradeName>
    <deviceName>Triplex Real-time PCR Detection Kit for Group A Rotavirus / Norovirus GI / Norovirus GII</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2593YH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:03.392Z</lastUpdated>
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    <udiDi>06974323011354</udiDi>
    <basicUdiDi>B-06974323011354</basicUdiDi>
    <tradeName>06974323011354</tradeName>
    <deviceName>Triplex Real-time PCR Detection Kit for Group A Rotavirus / Norovirus GI / Norovirus GII</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2593YH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:02.614Z</lastUpdated>
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    <udiDi>06974323011347</udiDi>
    <basicUdiDi>B-06974323011347</basicUdiDi>
    <tradeName>06974323011347</tradeName>
    <deviceName>Triple Real-time PCR Detection Kit for Salmonella / Shigella / Vibrio Cholerae</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D1473</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:02.176Z</lastUpdated>
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    <udiDi>06974323011330</udiDi>
    <basicUdiDi>B-06974323011330</basicUdiDi>
    <tradeName>06974323011330</tradeName>
    <deviceName>Triple Real-time PCR Detection Kit for Salmonella / Shigella / Vibrio Cholerae</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D1473</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:02.021Z</lastUpdated>
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    <udiDi>06973843229256</udiDi>
    <basicUdiDi>B-06973843229256</basicUdiDi>
    <tradeName>CentriDxTM Gastrointestinal Pathogen Panel Ⅰ</tradeName>
    <deviceName>CentriDxTM Gastrointestinal Pathogen Panel Ⅰ</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ87S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:40:09.201Z</lastUpdated>
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    <udiDi>06973642381834</udiDi>
    <basicUdiDi>B-06973642381834</basicUdiDi>
    <tradeName>06973642381834</tradeName>
    <deviceName>Tigsun Adeno/Rota/Noro Virus Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:27:01.679Z</lastUpdated>
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    <tradeName>06973642381827</tradeName>
    <deviceName>Tigsun Adeno/Rota/Noro Virus Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:27:00.865Z</lastUpdated>
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    <tradeName>06973642381810</tradeName>
    <deviceName>Tigsun Adeno/Rota/Noro Virus Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:56.857Z</lastUpdated>
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