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<eudamedExport entity="devices">
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    <udiDi>D-INRA-R635D6</udiDi>
    <basicUdiDi>B-INRA-R635D6</basicUdiDi>
    <tradeName>Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette</tradeName>
    <deviceName>Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INRA-R635</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:06.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IARl-535QX</udiDi>
    <basicUdiDi>B-IARl-535QX</basicUdiDi>
    <tradeName>Adenovirus, RSV and lnfluenza А+В Combo Rapid Test Cassette</tradeName>
    <deviceName>Adenovirus, RSV and lnfluenza А+В Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IARl-535</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:29:47.022Z</lastUpdated>
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  <row>
    <udiDi>D-GBS-P1-10Y4</udiDi>
    <basicUdiDi>B-GBS-P1-10Y4</basicUdiDi>
    <tradeName>GBS Test</tradeName>
    <deviceName>GBS Test</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBS-P1-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:29:21.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440258759</udiDi>
    <basicUdiDi>84354402MDXSEXUALC_BHHTGT</basicUdiDi>
    <tradeName>VIASURE HSV-1, HSV-2 &amp; Treponema pallidum Assay for BD MAX™ System</tradeName>
    <deviceName>VIASURE HSV-1, HSV-2 &amp; Treponema pallidum Assay for BD MAX™ System</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>444222</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:15:01.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440242475</udiDi>
    <basicUdiDi>84354402MDXRESPD_BBR1GR</basicUdiDi>
    <tradeName>VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System</tradeName>
    <deviceName>VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>444221</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:14:43.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440208709</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ106L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:14:42.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260753890259</udiDi>
    <basicUdiDi>426075389fbc118UB</basicUdiDi>
    <tradeName>res6plex direct RT-PCR</tradeName>
    <deviceName>res6plex direct RT-PCR</deviceName>
    <manufacturerName>FRIZ Biochem GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017533</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FBC118</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:01:54.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440239123</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ101L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:19.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440239130</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ101H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:17.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440208716</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ106H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:15.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440208723</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ112L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:14.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440208730</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ112H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:58.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440208747</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ113L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:53.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440208754</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ113H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:31.366Z</lastUpdated>
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  <row>
    <udiDi>08435440213369</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ196T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:30.699Z</lastUpdated>
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  <row>
    <udiDi>08435440239161</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:29.968Z</lastUpdated>
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    <udiDi>08435440211952</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ136</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:29.095Z</lastUpdated>
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  <row>
    <udiDi>08435440211969</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ172</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:28.636Z</lastUpdated>
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    <udiDi>08435440239147</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ101LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:28.075Z</lastUpdated>
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    <udiDi>08435440239154</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHZ7D</basicUdiDi>
    <tradeName>VIASURE Herpes virus 1, Herpes virus 2 &amp; Varicella Zoster Virus Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HHZ101HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:27.346Z</lastUpdated>
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