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<eudamedExport entity="devices">
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    <udiDi>06944904024752</udiDi>
    <basicUdiDi>694490400041a-HBDH*****EM</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase Kit (DGKC Method)</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase Kit (DGKC Method)</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000819-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:42:55.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942253005941</udiDi>
    <basicUdiDi>69422530000062NL</basicUdiDi>
    <tradeName>AutoChem HBDH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Biochemistry Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038143</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>360105HBD000S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:30:58.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305767</udiDi>
    <basicUdiDi>B-06936895305767</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（710）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:22:25.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305750</udiDi>
    <basicUdiDi>B-06936895305750</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（707）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:22:24.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305743</udiDi>
    <basicUdiDi>B-06936895305743</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:64mL×2  R2:16mL×2（794）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:22:20.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305736</udiDi>
    <basicUdiDi>B-06936895305736</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:12mL×2（798）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:22:19.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305729</udiDi>
    <basicUdiDi>B-06936895305729</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:64mL×6   R2:48mL×2（795）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:22:18.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305712</udiDi>
    <basicUdiDi>B-06936895305712</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50ml×2    R2:25ml×1（793）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:22:17.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305705</udiDi>
    <basicUdiDi>B-06936895305705</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:80ml×1     R2:20ml×1（703）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:22:13.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R02517ZU</udiDi>
    <basicUdiDi>B-R02517ZU</basicUdiDi>
    <tradeName>D-R02517ZU</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase Assay Reagent Kit (α-Oxobutyric Method)</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>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02517</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:22.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R02516ZS</udiDi>
    <basicUdiDi>B-R02516ZS</basicUdiDi>
    <tradeName>D-R02516ZS</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase Assay Reagent Kit (α-Oxobutyric Method)</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>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02516</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:21.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R02515ZQ</udiDi>
    <basicUdiDi>B-R02515ZQ</basicUdiDi>
    <tradeName>D-R02515ZQ</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase Assay Reagent Kit (α-Oxobutyric Method)</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>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02515</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:20.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R02514ZN</udiDi>
    <basicUdiDi>B-R02514ZN</basicUdiDi>
    <tradeName>D-R02514ZN</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase Assay Reagent Kit (α-Oxobutyric Method)</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>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02514</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:16.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R02512ZJ</udiDi>
    <basicUdiDi>B-R02512ZJ</basicUdiDi>
    <tradeName>D-R02512ZJ</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase Assay Reagent Kit (α-Oxobutyric Method)</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>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02512</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:15.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-777</udiDi>
    <basicUdiDi>B-6-777</basicUdiDi>
    <tradeName>D-6-777</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase Reagent Kit (α-ketobutyric Acid Substrate Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U84485040M, U84489060M, U84485020M, U84422060M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:12.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH050235474</udiDi>
    <basicUdiDi>B-ECH050235474</basicUdiDi>
    <tradeName>D-ECH050235474</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0502354</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:19.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05013546V</udiDi>
    <basicUdiDi>B-ECH05013546V</basicUdiDi>
    <tradeName>D-ECH05013546V</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0501354</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:33.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH020520968</udiDi>
    <basicUdiDi>B-ECH020520968</basicUdiDi>
    <tradeName>D-ECH020520968</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0205209</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:44.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01012094X</udiDi>
    <basicUdiDi>B-ECH01012094X</basicUdiDi>
    <tradeName>D-ECH01012094X</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase (α-HBDH)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101209</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:18.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT18328E</udiDi>
    <basicUdiDi>B-DT18328E</basicUdiDi>
    <tradeName>D-DT18328E</tradeName>
    <deviceName>beta-Hydroxybutyrate, Enzymatic, UV</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT1832</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:12.956Z</lastUpdated>
  </row>
</eudamedExport>