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<eudamedExport entity="devices">
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    <udiDi>05700572033127</udiDi>
    <basicUdiDi>570057R0301P3007C009101MU</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human BCL2 Oncoprotein, Clone 124, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human BCL2 Oncoprotein, Clone 124, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA614</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:52:51.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R159163H</udiDi>
    <basicUdiDi>B-R159163H</basicUdiDi>
    <tradeName>D-R159163H</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15916</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:40.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R159153F</udiDi>
    <basicUdiDi>B-R159153F</basicUdiDi>
    <tradeName>D-R159153F</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15915</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:39.615Z</lastUpdated>
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  <row>
    <udiDi>D-R159143D</udiDi>
    <basicUdiDi>B-R159143D</basicUdiDi>
    <tradeName>D-R159143D</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15914</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:38.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R159133B</udiDi>
    <basicUdiDi>B-R159133B</basicUdiDi>
    <tradeName>D-R159133B</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15913</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:38.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1591239</udiDi>
    <basicUdiDi>B-R1591239</basicUdiDi>
    <tradeName>D-R1591239</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15912</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:33.990Z</lastUpdated>
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  <row>
    <udiDi>D-R1591137</udiDi>
    <basicUdiDi>B-R1591137</basicUdiDi>
    <tradeName>D-R1591137</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15911</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:33.210Z</lastUpdated>
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  <row>
    <udiDi>00630414471235</udiDi>
    <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>
  </row>
  <row>
    <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>
  <row>
    <udiDi>D-697994388Ir0773XFM</udiDi>
    <basicUdiDi>B-697994388Ir0773XFM</basicUdiDi>
    <tradeName>D-697994388Ir0773XFM</tradeName>
    <deviceName>CRP/PCT Test Panel</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir077</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:25:49.026Z</lastUpdated>
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  <row>
    <udiDi>D-697994388Ir0763VFC</udiDi>
    <basicUdiDi>B-697994388Ir0763VFC</basicUdiDi>
    <tradeName>D-697994388Ir0763VFC</tradeName>
    <deviceName>CRP/SAA Test Panel</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir076</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:25:46.841Z</lastUpdated>
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  <row>
    <udiDi>D-697994388Ir0743RES</udiDi>
    <basicUdiDi>B-697994388Ir0743RES</basicUdiDi>
    <tradeName>D-697994388Ir0743RES</tradeName>
    <deviceName>SAA Serum Amyloid A Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir074</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:25:42.563Z</lastUpdated>
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  <row>
    <udiDi>D-697994388Ir0733PEH</udiDi>
    <basicUdiDi>B-697994388Ir0733PEH</basicUdiDi>
    <tradeName>D-697994388Ir0733PEH</tradeName>
    <deviceName>PCT Procalcitonin Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir073</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:25:41.506Z</lastUpdated>
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  <row>
    <udiDi>D-697994388Ir0753TF3</udiDi>
    <basicUdiDi>B-697994388Ir0753TF3</basicUdiDi>
    <tradeName>D-697994388Ir0753TF3</tradeName>
    <deviceName>IL-6 Interleukin-6 Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir075</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:25:40.730Z</lastUpdated>
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  <row>
    <udiDi>D-697994388Ir0723ME6</udiDi>
    <basicUdiDi>B-697994388Ir0723ME6</basicUdiDi>
    <tradeName>D-697994388Ir0723ME6</tradeName>
    <deviceName>hs-CRP High Sensitivity C-Reactive Protein Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir072</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:25:32.824Z</lastUpdated>
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    <udiDi>D-697994388Ir0713KDV</udiDi>
    <basicUdiDi>B-697994388Ir0713KDV</basicUdiDi>
    <tradeName>D-697994388Ir0713KDV</tradeName>
    <deviceName>CRP C-Reactive Protein Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir071</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:25:32.296Z</lastUpdated>
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  <row>
    <udiDi>07649990065076</udiDi>
    <basicUdiDi>B-07649990065076</basicUdiDi>
    <tradeName>PapilloDia Rapid Test</tradeName>
    <deviceName>PapilloDia Rapid Test</deviceName>
    <manufacturerName>GaDia SA</manufacturerName>
    <manufacturerSrn>CH-MF-000031123</manufacturerSrn>
    <authorisedRepresentativeName>ER Egészségügyi, Kereskedelmi és Szolgáltató Kft.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000030559</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CER-020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:03:03.399Z</lastUpdated>
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  <row>
    <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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    <udiDi>06972227432336</udiDi>
    <basicUdiDi>B-06972227432336</basicUdiDi>
    <tradeName>06972227432336</tradeName>
    <deviceName>Lung cancer associated protein Exosome Kit (immunostaining method)</deviceName>
    <manufacturerName>Qingdao Raisecare Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033899</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:47:17.326Z</lastUpdated>
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    <udiDi>06972227432329</udiDi>
    <basicUdiDi>B-06972227432329</basicUdiDi>
    <tradeName>06972227432329</tradeName>
    <deviceName>Lung cancer associated protein Exosome Kit (immunostaining method)</deviceName>
    <manufacturerName>Qingdao Raisecare Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033899</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:47:16.346Z</lastUpdated>
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