<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936415908058</udiDi>
    <basicUdiDi>69449040004V-ProGRP****FH</basicUdiDi>
    <tradeName>ProGRP(CLIA)</tradeName>
    <deviceName>ProGRP（CLIA）、ProGRP Calibrators、ProGRP 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>W0102030121</emdnCode>
    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010084-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:17.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415908034</udiDi>
    <basicUdiDi>69449040004H-RM-Con****NJ</basicUdiDi>
    <tradeName>Reproductive Multi Control</tradeName>
    <deviceName>Reproductive 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-008890-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:16.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415904159</udiDi>
    <basicUdiDi>69449040004JFER********AD</basicUdiDi>
    <tradeName>Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName>Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay Method)、FER 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-006175-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:16.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415904142</udiDi>
    <basicUdiDi>69449040004JTRF********T4</basicUdiDi>
    <tradeName>Transferrin Kit (Immunoturbidimetric Assay Method)</tradeName>
    <deviceName>Transferrin Kit (Immunoturbidimetric Assay Method)、TRF 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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-006177-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:15.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415904128</udiDi>
    <basicUdiDi>69449040004JMALB*******NV</basicUdiDi>
    <tradeName>Microalbumin Kit (Immunoturbidimetric Assay Method)</tradeName>
    <deviceName>Microalbumin</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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-006173-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:14.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900724</udiDi>
    <basicUdiDi>69449040004S-LFM-Con***W4</basicUdiDi>
    <tradeName>Liver Fibrosis Multi Control</tradeName>
    <deviceName>Liver Fibrosis 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010249-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:13.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900588</udiDi>
    <basicUdiDi>69449040004S-PCT*******M3</basicUdiDi>
    <tradeName>Procalcitonin(CLIA)</tradeName>
    <deviceName>Procalcitonin(CLIA)、PCT Calibrators、PCT 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010703-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:12.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900564</udiDi>
    <basicUdiDi>69449040004S-C4********6S</basicUdiDi>
    <tradeName>Collagen Type IV (CLIA)</tradeName>
    <deviceName>Collagen Type IV (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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010718-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:12.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900540</udiDi>
    <basicUdiDi>69449040004S-PIIINP****VT</basicUdiDi>
    <tradeName>N-terminal Peptide of Procollagen Type III (CLIA)</tradeName>
    <deviceName>N-terminal Peptide of Procollagen Type III (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>W0102120104</emdnCode>
    <emdnDescription>PROCOLLAGEN III AMINO TERMINAL PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010717-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:11.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900526</udiDi>
    <basicUdiDi>69449040004S-HA********KX</basicUdiDi>
    <tradeName>Hyaluronic acid (CLIA)</tradeName>
    <deviceName>Hyaluronic acid (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>W0102120103</emdnCode>
    <emdnDescription>HYALURONIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010716-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:10.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900502</udiDi>
    <basicUdiDi>69449040004S-LN********YW</basicUdiDi>
    <tradeName>Laminin (CLIA)</tradeName>
    <deviceName>Laminin (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>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010715-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:09.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900489</udiDi>
    <basicUdiDi>69449040004V-PG2*******7T</basicUdiDi>
    <tradeName>Pepsinogen Ⅱ (CLIA)</tradeName>
    <deviceName>Pepsinogen Ⅱ （CLIA）、PGⅡ Calibrators</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010087-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:08.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900465</udiDi>
    <basicUdiDi>69449040004V-PG1*******78</basicUdiDi>
    <tradeName>Pepsinogen I (CLIA)</tradeName>
    <deviceName>Pepsinogen I （CLIA）、PGⅠCalibrators</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010086-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:08.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415900441</udiDi>
    <basicUdiDi>69449040004S-rT3*******8N</basicUdiDi>
    <tradeName>Reverse Triiodothyronine (CLIA)</tradeName>
    <deviceName>Reverse Triiodothyronine (CLIA)、rT3 Calibrators、rT3 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>W01020404</emdnCode>
    <emdnDescription>REVERSE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010692-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:07.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053159715</udiDi>
    <basicUdiDi>69449040AB310000625</basicUdiDi>
    <tradeName>Urine Analyzer</tradeName>
    <deviceName>Urine Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-610T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:40:59.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053159388</udiDi>
    <basicUdiDi>69449040AB3000019ZW</basicUdiDi>
    <tradeName>Auto Hematology Analyzer</tradeName>
    <deviceName>Auto Hematology Analyzer</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></emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Counter 60 AL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:40:58.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053158695</udiDi>
    <basicUdiDi>69449040004S-AMH*******7J</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone (CLIA)</tradeName>
    <deviceName>Anti-Mullerian Hormone (CLIA)、AMH 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></emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-065971-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:40:57.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053158152</udiDi>
    <basicUdiDi>69449040004H-LH********FV</basicUdiDi>
    <tradeName>Luteinizing Hormone (CLIA)</tradeName>
    <deviceName>Luteinizing Hormone（CLIA）、LH Calibrators</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></emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-064651-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:40:56.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053158107</udiDi>
    <basicUdiDi>69449040004L-Cortisol**MW</basicUdiDi>
    <tradeName>Cortisol (CLIA)</tradeName>
    <deviceName>Cortisol(CLIA)、Cortisol Calibrators</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></emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-064665-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:40:56.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053157940</udiDi>
    <basicUdiDi>69449040004L-DHEA-S****PF</basicUdiDi>
    <tradeName>Dehydroepiandrosterone sulfate(CLIA)</tradeName>
    <deviceName>Dehydroepiandrosterone sulfate(CLIA)、DHEA-S Calibrators</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></emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-064667-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:40:55.297Z</lastUpdated>
  </row>
</eudamedExport>