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<eudamedExport entity="devices">
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    <udiDi>06903053021456</udiDi>
    <basicUdiDi>69449040AB74000175M</basicUdiDi>
    <tradeName>ToRCH IgM Positive Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-024840-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053021500</udiDi>
    <basicUdiDi>69449040AB74000185P</basicUdiDi>
    <tradeName>ToRCH IgG/IgM Negative Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-024825-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053021524</udiDi>
    <basicUdiDi>69449040AB74000165K</basicUdiDi>
    <tradeName>ToRCH IgG Positive Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-024832-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053021579</udiDi>
    <basicUdiDi>69449040AB74000185P</basicUdiDi>
    <tradeName>ToRCH IgG/IgM Negative Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-024826-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053059978</udiDi>
    <basicUdiDi>69449040AB74000255L</basicUdiDi>
    <tradeName>Toxo IgG Avidity Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029874-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053059992</udiDi>
    <basicUdiDi>69449040AB74000255L</basicUdiDi>
    <tradeName>Toxo IgG Avidity Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029876-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053060004</udiDi>
    <basicUdiDi>69449040AB74000255L</basicUdiDi>
    <tradeName>Toxo IgG Avidity Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029878-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053060011</udiDi>
    <basicUdiDi>69449040AB74000255L</basicUdiDi>
    <tradeName>Toxo IgG Avidity Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029879-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053060035</udiDi>
    <basicUdiDi>69449040AB74000255L</basicUdiDi>
    <tradeName>Toxoplasma gondii IgG Avidity（CLIA）</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG - AVIDITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029867-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053060066</udiDi>
    <basicUdiDi>69449040AB74000255L</basicUdiDi>
    <tradeName>Toxo IgG Avidity Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029872-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053060103</udiDi>
    <basicUdiDi>69449040AB74000255L</basicUdiDi>
    <tradeName>Toxo IgG Avidity Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029875-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053060127</udiDi>
    <basicUdiDi>69449040AB74000255L</basicUdiDi>
    <tradeName>Toxoplasma gondii IgG Avidity(CLIA)</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG - AVIDITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029863-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053060134</udiDi>
    <basicUdiDi>69449040AB74000255L</basicUdiDi>
    <tradeName>Toxo IgG Avidity Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-029877-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053070485</udiDi>
    <basicUdiDi>69449040AB74000435N</basicUdiDi>
    <tradeName>HAV IgM and HEV IgM Multi Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043941-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053070522</udiDi>
    <basicUdiDi>69449040AB74000435N</basicUdiDi>
    <tradeName>HAV IgM and HEV IgM Multi Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043944-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053070539</udiDi>
    <basicUdiDi>69449040AB74000435N</basicUdiDi>
    <tradeName>HAV IgM and HEV IgM Multi Control</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043942-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617419747</udiDi>
    <basicUdiDi>69506174IM429315ER</basicUdiDi>
    <tradeName>06950617419747</tradeName>
    <deviceName>HAV IgM Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4291315</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:46:31.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760369291200</udiDi>
    <basicUdiDi>376036929SMI001EV</basicUdiDi>
    <tradeName>SeroQal ALINI 6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>270428</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T03:00:33.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300186</udiDi>
    <basicUdiDi>B-06937287300186</basicUdiDi>
    <tradeName>06937287300186</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×1 mL (2 levels)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:51:29.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300179</udiDi>
    <basicUdiDi>B-06937287300179</basicUdiDi>
    <tradeName>06937287300179</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080907</emdnCode>
    <emdnDescription>MULTICONSTITUENT STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6×1 mL (6 levels)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:51:27.597Z</lastUpdated>
  </row>
</eudamedExport>