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<eudamedExport entity="devices">
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    <udiDi>06944904091044</udiDi>
    <basicUdiDi>69449040XQSJ-003W******GZ</basicUdiDi>
    <tradeName>C-Reactive Protein (CRP) Kit (Latex Immunoturbidimetric Method)</tradeName>
    <deviceName>C-Reactive Protein (CRP) Kit (Latex Immunoturbidimetric 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004891-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:00:07.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904053547</udiDi>
    <basicUdiDi>69449040004MRF*********W9</basicUdiDi>
    <tradeName>Rheumatoid Factor Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Rheumatoid Factor Kit (Immunoturbidimetric Method)、Rheumatoid Factor Calibrator</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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004632-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:54:10.080Z</lastUpdated>
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  <row>
    <udiDi>06903053071178</udiDi>
    <basicUdiDi>69449040004MASO********KJ</basicUdiDi>
    <tradeName>Antistreptolysin “O” Kit (Latex Immunoturbidimetric Method)</tradeName>
    <deviceName>Antistreptolysin “O”</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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-044232-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:08.936Z</lastUpdated>
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  <row>
    <udiDi>06903053029100</udiDi>
    <basicUdiDi>69449040007C-SAAS-1****MA</basicUdiDi>
    <tradeName>Serum Amyloid A (SAA) Kit (Latex Particle-Enhanced Immunonephelometry Method)</tradeName>
    <deviceName>Serum Amyloid A (SAA) Kit (Latex Particle-Enhanced Immunonephelometry 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-020881-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:29.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053027236</udiDi>
    <basicUdiDi>69449040007BCRPC-II****JU</basicUdiDi>
    <tradeName>C-Reactive Protein (CRP) Kit  (Latex Particle-Enhanced Immunonephelometry Method）</tradeName>
    <deviceName>C-Reactive Protein (CRP) Kit  (Latex Particle-Enhanced Immunonephelometry 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-025162-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:19.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904037400</udiDi>
    <basicUdiDi>69449040004GRF*********PB</basicUdiDi>
    <tradeName>Rheumatoid Factor Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName>Rheumatoid Factor Kit (Particle-enhanced Immunoturbidimetric Assay Method)、Rheumatoid Factor Calibrator</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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002159-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:44:09.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024974</udiDi>
    <basicUdiDi>694490400044CRP********RF</basicUdiDi>
    <tradeName>C-Reactive Protein Kit (Turbidimetry Method)</tradeName>
    <deviceName>C-Reactive Protein Kit (Turbidimetry 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000841-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:17.816Z</lastUpdated>
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  <row>
    <udiDi>06926802604403</udiDi>
    <basicUdiDi>69268026MD72C00001V3</basicUdiDi>
    <tradeName>06926802604403</tradeName>
    <deviceName>Anti-CCP (CLIA)</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MCL03601E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:29.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802603130</udiDi>
    <basicUdiDi>69268026MD71E00001VC</basicUdiDi>
    <tradeName>06926802603130</tradeName>
    <deviceName>hs-CRP+CRP（CLIA）</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL02001E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:02.014Z</lastUpdated>
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  <row>
    <udiDi>06925912719939</udiDi>
    <basicUdiDi>692591270265HP</basicUdiDi>
    <tradeName>iFlash-CRP</tradeName>
    <deviceName>iFlash-CRP</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:50.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912718666</udiDi>
    <basicUdiDi>692591270044H5</basicUdiDi>
    <tradeName>iFlash-Anti-CCP</tradeName>
    <deviceName>iFlash-Anti-CCP</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89017G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:49.868Z</lastUpdated>
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  <row>
    <udiDi>06925912717904</udiDi>
    <basicUdiDi>692591270072HA</basicUdiDi>
    <tradeName>iFlash-RF</tradeName>
    <deviceName>iFlash-RF</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89038Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:33.202Z</lastUpdated>
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  <row>
    <udiDi>06925912717898</udiDi>
    <basicUdiDi>692591270074HE</basicUdiDi>
    <tradeName>iFlash-RF IgM</tradeName>
    <deviceName>iFlash-RF IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89036M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:32.397Z</lastUpdated>
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  <row>
    <udiDi>06925912717881</udiDi>
    <basicUdiDi>692591270073HC</basicUdiDi>
    <tradeName>iFlash-RF IgG</tradeName>
    <deviceName>iFlash-RF IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89035G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:31.590Z</lastUpdated>
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  <row>
    <udiDi>06925912717874</udiDi>
    <basicUdiDi>692591270069HM</basicUdiDi>
    <tradeName>iFlash-RA33 IgG</tradeName>
    <deviceName>iFlash-RA33 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89026G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:30.779Z</lastUpdated>
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  <row>
    <udiDi>04050598197107</udiDi>
    <basicUdiDi>B-04050598197107</basicUdiDi>
    <tradeName>CRP ELISA</tradeName>
    <deviceName>CRP ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9710s</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404035100264</udiDi>
    <basicUdiDi>54040351221020BU</basicUdiDi>
    <tradeName>CRP Latex</tradeName>
    <deviceName>CRP Latex</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:45:55.600Z</lastUpdated>
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    <udiDi>05051700017343</udiDi>
    <basicUdiDi>5051700LK189.OPT8W</basicUdiDi>
    <tradeName>Optilite® Anti-streptolysin O Kit</tradeName>
    <deviceName>Optilite® Anti-streptolysin O Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK189.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:01.642Z</lastUpdated>
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    <udiDi>04931921001691</udiDi>
    <basicUdiDi>4931921IVD0014NU</basicUdiDi>
    <tradeName>Celltac chemi CRP 4N CR-421W</tradeName>
    <deviceName>C-REACTIVE PROTEIN</deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-421W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:22:16.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700823605</udiDi>
    <basicUdiDi>37017008IRFA009E</basicUdiDi>
    <tradeName>RHEUMATOID FACTOR</tradeName>
    <deviceName>RHEUMATOID FACTOR</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRFA-0230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:51:40.106Z</lastUpdated>
  </row>
</eudamedExport>