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    <basicUdiDi>69510458SF_PlGFBZ</basicUdiDi>
    <tradeName>06951045811462</tradeName>
    <deviceName>SuperFlex PlGF Kit</deviceName>
    <manufacturerName>Suzhou Sym-Bio Lifescience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012847</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY428QG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:20:14.835Z</lastUpdated>
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    <udiDi>04260157632196</udiDi>
    <basicUdiDi>426015763859BPlGFpluKXXKY</basicUdiDi>
    <tradeName>B·R·A·H·M·S PlGF plus KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S PlGF plus KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>859075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:47.270Z</lastUpdated>
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    <udiDi>00630414290355</udiDi>
    <basicUdiDi>0405686902128VC</basicUdiDi>
    <tradeName>Atellica IM Placental Growth Factor (PlGF)</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Placental Growth Factor</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11200232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:49.243Z</lastUpdated>
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    <udiDi>D-IM4492155LX</udiDi>
    <basicUdiDi>B-IM4492155LX</basicUdiDi>
    <tradeName>D-IM4492155LX</tradeName>
    <deviceName>GDF-15 Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4492155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:21.195Z</lastUpdated>
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    <udiDi>D-IM4491155LQ</udiDi>
    <basicUdiDi>B-IM4491155LQ</basicUdiDi>
    <tradeName>D-IM4491155LQ</tradeName>
    <deviceName>GDF-15 Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4491155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:42.705Z</lastUpdated>
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    <udiDi>D-IM4407155JX</udiDi>
    <basicUdiDi>B-IM4407155JX</basicUdiDi>
    <tradeName>D-IM4407155JX</tradeName>
    <deviceName>GDF-15 Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:41.497Z</lastUpdated>
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    <udiDi>D-IM4406155JQ</udiDi>
    <basicUdiDi>B-IM4406155JQ</basicUdiDi>
    <tradeName>D-IM4406155JQ</tradeName>
    <deviceName>GDF-15 Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:36.297Z</lastUpdated>
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    <udiDi>D-IM4403155J3</udiDi>
    <basicUdiDi>B-IM4403155J3</basicUdiDi>
    <tradeName>D-IM4403155J3</tradeName>
    <deviceName>GDF-15 Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:21.502Z</lastUpdated>
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  <row>
    <udiDi>D-IM4402155HU</udiDi>
    <basicUdiDi>B-IM4402155HU</basicUdiDi>
    <tradeName>D-IM4402155HU</tradeName>
    <deviceName>GDF-15 Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:18:11.565Z</lastUpdated>
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    <udiDi>06974854621428</udiDi>
    <basicUdiDi>B-06974854621428</basicUdiDi>
    <tradeName>Placental Growth Factor/sFlt-1 Test</tradeName>
    <deviceName>Placental Growth Factor/sFlt-1 Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2208825</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:57:05.516Z</lastUpdated>
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  <row>
    <udiDi>06974854621381</udiDi>
    <basicUdiDi>B-06974854621381</basicUdiDi>
    <tradeName>Placental Growth Factor (PLGF) Test</tradeName>
    <deviceName>Placental Growth Factor (PLGF) Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2208425</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:59.130Z</lastUpdated>
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  <row>
    <udiDi>06974671102018</udiDi>
    <basicUdiDi>B-06974671102018</basicUdiDi>
    <tradeName>06974671102018</tradeName>
    <deviceName>Placental Growth Factor Diagnostic Kit (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-CK-A030</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:34.574Z</lastUpdated>
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  <row>
    <udiDi>06973642381568</udiDi>
    <basicUdiDi>B-06973642381568</basicUdiDi>
    <tradeName>06973642381568</tradeName>
    <deviceName>Tigsun PIGF Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:12.818Z</lastUpdated>
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    <udiDi>06973642381551</udiDi>
    <basicUdiDi>B-06973642381551</basicUdiDi>
    <tradeName>06973642381551</tradeName>
    <deviceName>Tigsun PIGF Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:12.017Z</lastUpdated>
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    <udiDi>06973642381544</udiDi>
    <basicUdiDi>B-06973642381544</basicUdiDi>
    <tradeName>06973642381544</tradeName>
    <deviceName>Tigsun PIGF Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:26:11.213Z</lastUpdated>
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    <udiDi>06973642381537</udiDi>
    <basicUdiDi>B-06973642381537</basicUdiDi>
    <tradeName>06973642381537</tradeName>
    <deviceName>Tigsun PIGF Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:21.513Z</lastUpdated>
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    <udiDi>06973642381520</udiDi>
    <basicUdiDi>B-06973642381520</basicUdiDi>
    <tradeName>06973642381520</tradeName>
    <deviceName>Tigsun PIGF Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:20.709Z</lastUpdated>
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    <udiDi>06973642381513</udiDi>
    <basicUdiDi>B-06973642381513</basicUdiDi>
    <tradeName>06973642381513</tradeName>
    <deviceName>Tigsun PIGF Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:19.909Z</lastUpdated>
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    <udiDi>06973642381506</udiDi>
    <basicUdiDi>B-06973642381506</basicUdiDi>
    <tradeName>06973642381506</tradeName>
    <deviceName>Tigsun PIGF Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:18.306Z</lastUpdated>
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    <udiDi>06973642381490</udiDi>
    <basicUdiDi>B-06973642381490</basicUdiDi>
    <tradeName>06973642381490</tradeName>
    <deviceName>Tigsun PIGF Antigen Rapid Test (FIA)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:24:15.910Z</lastUpdated>
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