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    <basicUdiDi>0405686901814VV</basicUdiDi>
    <tradeName>ADVIA Centaur HER-2/neu</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_H2n</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030301</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10308994</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:48:34.717Z</lastUpdated>
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    <udiDi>00630414599151</udiDi>
    <basicUdiDi>0405686901814VV</basicUdiDi>
    <tradeName>Atellica IM HER-2/neu (H2n)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_H2n</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030301</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995591</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:11.408Z</lastUpdated>
  </row>
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    <udiDi>06976753470572</udiDi>
    <basicUdiDi>B-06976753470572</basicUdiDi>
    <tradeName>Human Epidermal GrowthFactor Receptor 2（HER-2）Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030301</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KH015</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:56:20.764Z</lastUpdated>
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  <row>
    <udiDi>06971792051416</udiDi>
    <basicUdiDi>B-06971792051416</basicUdiDi>
    <tradeName>Human Epidermal GrowthFactor Receptor 2（HER-2）Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030301</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KA022</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:53:20.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716404717</udiDi>
    <basicUdiDi>69713904301237K</basicUdiDi>
    <tradeName>HOKAPI™ HER-2/NEU</tradeName>
    <deviceName>HOKAPI™ HER-2/NEU</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030301</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010123001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:44.593Z</lastUpdated>
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  <row>
    <udiDi>06971390439746</udiDi>
    <basicUdiDi>69713904301237K</basicUdiDi>
    <tradeName>HOKAPI™ HER-2/NEU</tradeName>
    <deviceName>HOKAPI™ HER-2/NEU</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030301</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010123101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:02:11.137Z</lastUpdated>
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  <row>
    <udiDi>06939716404724</udiDi>
    <basicUdiDi>69713904301237K</basicUdiDi>
    <tradeName>HOKAPI™ HER-2/NEU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030301</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010123601</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:06:30.664Z</lastUpdated>
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