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<eudamedExport entity="devices">
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    <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>00630414600536</udiDi>
    <basicUdiDi>0405686902037V8</basicUdiDi>
    <tradeName>Atellica IM Rub G QC</tradeName>
    <deviceName></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>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995671</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:38.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956111</udiDi>
    <basicUdiDi>0816784020096YG</basicUdiDi>
    <tradeName>Optitrol NAT HCV Screening, 10x 1,2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</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>NT01022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:35.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956173</udiDi>
    <basicUdiDi>0816784020095YE</basicUdiDi>
    <tradeName>Optitrol NAT HIV Screening, 10x 1,2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</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>NT01032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:35.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956210</udiDi>
    <basicUdiDi>0816784020102XJ</basicUdiDi>
    <tradeName>Optitrol NAT HIV-2, 10x 1,2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</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>NT01036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:35.552Z</lastUpdated>
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    <udiDi>00850075956272</udiDi>
    <basicUdiDi>0816784020093YA</basicUdiDi>
    <tradeName>Optitrol NAT NEG, 10x 1,2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</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>NT01052</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:35.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956326</udiDi>
    <basicUdiDi>0816784020092Y8</basicUdiDi>
    <tradeName>Optitrol NAT Triplex, 5x 1,2 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</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>NT01041</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:35.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956340</udiDi>
    <basicUdiDi>0816784020097YJ</basicUdiDi>
    <tradeName>Optitrol Orange, 1x pos, 1mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11069</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:35.418Z</lastUpdated>
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  <row>
    <udiDi>00850075956357</udiDi>
    <basicUdiDi>0816784020097YJ</basicUdiDi>
    <tradeName>Optitrol Orange, 4x pos, 5mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11061</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:35.402Z</lastUpdated>
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