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<eudamedExport entity="devices">
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    <udiDi>08806133048498</udiDi>
    <basicUdiDi>880613306069DH</basicUdiDi>
    <tradeName>Boditech PSA Control</tradeName>
    <deviceName>Boditech PSA Control</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-250</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:54.714Z</lastUpdated>
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    <udiDi>17350066140579</udiDi>
    <basicUdiDi>7350066140579M</basicUdiDi>
    <tradeName>AMH Control</tradeName>
    <deviceName>AMH Control</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>660-20</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:24:21.489Z</lastUpdated>
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    <udiDi>06970493098911</udiDi>
    <basicUdiDi>6970493090506005NZ</basicUdiDi>
    <tradeName>Serum Amyloid A Protein Control</tradeName>
    <deviceName>Serum Amyloid A Protein Control</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0006-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:20:16.034Z</lastUpdated>
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    <udiDi>06970493097174</udiDi>
    <basicUdiDi>6970493090506002NT</basicUdiDi>
    <tradeName>C-Reactive Protein Control</tradeName>
    <deviceName>C-Reactive Protein Control</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0003-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:20:11.207Z</lastUpdated>
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  <row>
    <udiDi>06942359522656</udiDi>
    <basicUdiDi>697015090000130GW</basicUdiDi>
    <tradeName>Thyroid Speciality Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK0501L106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:48:40.838Z</lastUpdated>
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  <row>
    <udiDi>06942359520560</udiDi>
    <basicUdiDi>697015090000127H9</basicUdiDi>
    <tradeName>Autoimmune Maker Control I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKE010101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:48:17.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904096896</udiDi>
    <basicUdiDi>69449040004L-TM-Con****UY</basicUdiDi>
    <tradeName>Tumor Marker Multi Control</tradeName>
    <deviceName>Tumor Marker Multi Control</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-007373-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:00:24.504Z</lastUpdated>
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  <row>
    <udiDi>06903053114035</udiDi>
    <basicUdiDi>69449040AB74000575Z</basicUdiDi>
    <tradeName>17α-Hydroxyprogesterone (CLIA)</tradeName>
    <deviceName>17α-Hydroxyprogesterone (CLIA)、17α-Hydroxyprogesterone Control</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-054015-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:52:28.498Z</lastUpdated>
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  <row>
    <udiDi>06903053082754</udiDi>
    <basicUdiDi>69449040AB740004962</basicUdiDi>
    <tradeName>S100 Control</tradeName>
    <deviceName>S100 (CLIA) 、S100 Calibrators、S100 Control</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-032024-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:55.891Z</lastUpdated>
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  <row>
    <udiDi>06903053079693</udiDi>
    <basicUdiDi>69449040AB74000555V</basicUdiDi>
    <tradeName>hs-cTnT Control</tradeName>
    <deviceName>High Sensitivity Cardiac Troponin T （CLIA）, hs-cTnT Calibrators, hs-cTnT Control</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>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-046733-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:34.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053077552</udiDi>
    <basicUdiDi>69449040AB74000545T</basicUdiDi>
    <tradeName>Anti-CCP Control</tradeName>
    <deviceName>Antibody to cyclic citrullinated peptides (CLIA)</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>W0102152010</emdnCode>
    <emdnDescription>CONTROLS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-046688-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:28.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053077521</udiDi>
    <basicUdiDi>69449040AB74000535R</basicUdiDi>
    <tradeName>tIgE Control</tradeName>
    <deviceName>Total Immunoglobulin E</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>tIgE Control</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:27.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053074087</udiDi>
    <basicUdiDi>69449040AB74000645W</basicUdiDi>
    <tradeName>Total-P1NP/Osteocalcin/β-CTx Multi Control</tradeName>
    <deviceName>Total-P1NP/Osteocalcin/β-CTx Multi Control</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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-045130-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:16.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053068796</udiDi>
    <basicUdiDi>69449040AB74000305D</basicUdiDi>
    <tradeName>PIVKA-II Control</tradeName>
    <deviceName>PIVKA-II (CLIA)，PIVKA-II Calibrators，PIVKA-II Control</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-031983-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:01.639Z</lastUpdated>
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  <row>
    <udiDi>06903053060967</udiDi>
    <basicUdiDi>69449040AB74000295U</basicUdiDi>
    <tradeName>PG I/PG II/G-17 Multi Control</tradeName>
    <deviceName>PG I/PG II/G-17 Multi Control</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-031971-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:31.957Z</lastUpdated>
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  <row>
    <udiDi>06903053045018</udiDi>
    <basicUdiDi>69449040AB74000445Q</basicUdiDi>
    <tradeName>Growth Hormone Multi Control(H)</tradeName>
    <deviceName>Growth Hormone Multi Control (L), Growth Hormone Multi Control(H)</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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06903053045018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:34.298Z</lastUpdated>
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    <udiDi>06903053029469</udiDi>
    <basicUdiDi>69449040007C-SAACalCon*6S</basicUdiDi>
    <tradeName>Serum Amyloid A Control</tradeName>
    <deviceName>Serum Amyloid A Calibrator、Serum Amyloid A Control</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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-021029-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:45.613Z</lastUpdated>
  </row>
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    <udiDi>06925912738947</udiDi>
    <basicUdiDi>692591270139HH</basicUdiDi>
    <tradeName>Immunoassay Multi Control</tradeName>
    <deviceName>Immunoassay Multi Control</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC817</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:38:53.378Z</lastUpdated>
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    <udiDi>06925912738909</udiDi>
    <basicUdiDi>692591270353HM</basicUdiDi>
    <tradeName>Histones IgG Control</tradeName>
    <deviceName>Histones IgG Control</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>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC359</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:38:26.242Z</lastUpdated>
  </row>
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    <udiDi>06925912738893</udiDi>
    <basicUdiDi>692591270351HH</basicUdiDi>
    <tradeName>Androstenedione Control</tradeName>
    <deviceName>Androstenedione Control</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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:38:25.444Z</lastUpdated>
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</eudamedExport>