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    <udiDi>06974912093754</udiDi>
    <basicUdiDi>B-06974912093754</basicUdiDi>
    <tradeName>Mycoplasma hominis Real-time PCR Kit</tradeName>
    <deviceName>Mycoplasma hominis Real-time PCR Kit</deviceName>
    <manufacturerName>Nexlab Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047094</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITSZ094001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:02:07.597Z</lastUpdated>
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    <udiDi>06974912093747</udiDi>
    <basicUdiDi>B-06974912093747</basicUdiDi>
    <tradeName>Ureaplasma urealyticum Real-time PCR Kit</tradeName>
    <deviceName>Ureaplasma urealyticum Real-time PCR Kit</deviceName>
    <manufacturerName>Nexlab Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047094</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITSZ092001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:02:06.790Z</lastUpdated>
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    <udiDi>06974858560341</udiDi>
    <basicUdiDi>B-06974858560341</basicUdiDi>
    <tradeName>06974858560341</tradeName>
    <deviceName>Mycoplasma Pneumoniae (MP) Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P181H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:58:23.236Z</lastUpdated>
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    <udiDi>06974858560112</udiDi>
    <basicUdiDi>B-06974858560112</basicUdiDi>
    <tradeName>06974858560112</tradeName>
    <deviceName>Mycoplasma Pneumoniae (MP) Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P109H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:58:01.661Z</lastUpdated>
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    <udiDi>06974858560068</udiDi>
    <basicUdiDi>B-06974858560068</basicUdiDi>
    <tradeName>06974858560068</tradeName>
    <deviceName>Ureaplasma Urealyticum (UU) Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P178H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:57:59.221Z</lastUpdated>
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    <udiDi>06974858560051</udiDi>
    <basicUdiDi>B-06974858560051</basicUdiDi>
    <tradeName>06974858560051</tradeName>
    <deviceName>Ureaplasma Urealyticum (UU) Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P105H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:57:57.623Z</lastUpdated>
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    <udiDi>06974767392026</udiDi>
    <basicUdiDi>B-06974767392026</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE NG&amp;UU Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018011902-CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:05.588Z</lastUpdated>
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  <row>
    <udiDi>06974767392002</udiDi>
    <basicUdiDi>B-06974767392002</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE MG&amp;TV&amp;MH Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018012502-CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:04.753Z</lastUpdated>
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    <udiDi>06974767391555</udiDi>
    <basicUdiDi>B-06974767391555</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE NG&amp;UU Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018011905-CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:39.072Z</lastUpdated>
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  <row>
    <udiDi>06974767391517</udiDi>
    <basicUdiDi>B-06974767391517</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE MG&amp;TV&amp;MH Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018012505-CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:36.668Z</lastUpdated>
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  <row>
    <udiDi>06974323012986</udiDi>
    <basicUdiDi>B-06974323012986</basicUdiDi>
    <tradeName>06974323012986</tradeName>
    <deviceName>PCR-based Ureaplasma Urealyticum Test Kit (Fluorometric PCR)</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>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:21.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323012979</udiDi>
    <basicUdiDi>B-06974323012979</basicUdiDi>
    <tradeName>06974323012979</tradeName>
    <deviceName>PCR-based Ureaplasma Urealyticum Test Kit (Fluorometric PCR)</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>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:20.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323010883</udiDi>
    <basicUdiDi>B-06974323010883</basicUdiDi>
    <tradeName>06974323010883</tradeName>
    <deviceName>Real-time PCR Detection Kit for Mycoplasma Pneumoniae</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>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:44:07.914Z</lastUpdated>
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  <row>
    <udiDi>06974323010876</udiDi>
    <basicUdiDi>B-06974323010876</basicUdiDi>
    <tradeName>06974323010876</tradeName>
    <deviceName>Real-time PCR Detection Kit for Mycoplasma Pneumoniae</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>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:44:02.425Z</lastUpdated>
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  <row>
    <udiDi>06971042229503</udiDi>
    <basicUdiDi>B-06971042229503</basicUdiDi>
    <tradeName>UU/TV/MG Multiplex Real Time PCR Kit</tradeName>
    <deviceName>UU/TV/MG Multiplex Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0316-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:25.800Z</lastUpdated>
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  <row>
    <udiDi>06971042229480</udiDi>
    <basicUdiDi>B-06971042229480</basicUdiDi>
    <tradeName>Mycoplasma Hominis (MH)  Real Time PCR Kit</tradeName>
    <deviceName>Mycoplasma Hominis (MH)  Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0279-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:20.694Z</lastUpdated>
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    <udiDi>06971042229473</udiDi>
    <basicUdiDi>B-06971042229473</basicUdiDi>
    <tradeName>Mycoplasma Genitalium (MG)  Real Time PCR Kit</tradeName>
    <deviceName>Mycoplasma Genitalium (MG)  Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0278-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:19.827Z</lastUpdated>
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  <row>
    <udiDi>06971042229466</udiDi>
    <basicUdiDi>B-06971042229466</basicUdiDi>
    <tradeName>Ureaplasma parvum (UP) Real Time PCR Kit</tradeName>
    <deviceName>Ureaplasma parvum (UP) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0267-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:18.996Z</lastUpdated>
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    <udiDi>06971042229459</udiDi>
    <basicUdiDi>B-06971042229459</basicUdiDi>
    <tradeName>UU/MH/MG/TV Multiplex Real Time PCR Kit</tradeName>
    <deviceName>UU/MH/MG/TV Multiplex Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0252-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:14.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042229404</udiDi>
    <basicUdiDi>B-06971042229404</basicUdiDi>
    <tradeName>Ureaplasma Urealyticum (UU) Real Time PCR Kit</tradeName>
    <deviceName>Ureaplasma Urealyticum (UU) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-0015-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:04:26.575Z</lastUpdated>
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