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<eudamedExport entity="devices">
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    <udiDi>06903053070430</udiDi>
    <basicUdiDi>69449040AB41000032G</basicUdiDi>
    <tradeName>Automated Blood Culture System</tradeName>
    <deviceName>Automated Blood Culture System</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>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA-N120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:05.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053062220</udiDi>
    <basicUdiDi>69449040AB41000012C</basicUdiDi>
    <tradeName>Automated Dosing System</tradeName>
    <deviceName>Automated Dosing System</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>W02069001</emdnCode>
    <emdnDescription>AUTOSAMPLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:52.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053062213</udiDi>
    <basicUdiDi>69449040AB41000022E</basicUdiDi>
    <tradeName>Automated ID/AST Testing System</tradeName>
    <deviceName>Automated ID/AST Testing System</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>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:36.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053053044</udiDi>
    <basicUdiDi>69449040AB4000001ZU</basicUdiDi>
    <tradeName>Chemistry Analyzer</tradeName>
    <deviceName>Chemistry 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>W0201010107</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-1000M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:19.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053050715</udiDi>
    <basicUdiDi>69449040AB3100004ZW</basicUdiDi>
    <tradeName>Automatic Urinalysis System</tradeName>
    <deviceName>Automatic Urinalysis System</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-5300pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:17.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053043045</udiDi>
    <basicUdiDi>69449040AB320000128</basicUdiDi>
    <tradeName>Auto Coagulation Analyzer</tradeName>
    <deviceName>Auto Coagulation 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>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CX-6000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:32.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053040716</udiDi>
    <basicUdiDi>69449040AB3000015ZN</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Counter 31 AL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:23.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053040693</udiDi>
    <basicUdiDi>69449040AB3000010ZC</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Unicorn 5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:19.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053040648</udiDi>
    <basicUdiDi>69449040AB3000013ZJ</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Counter XS 20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:18.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053035729</udiDi>
    <basicUdiDi>69449040AB310000523</basicUdiDi>
    <tradeName>Sample Processing System</tradeName>
    <deviceName>Sample Processing System</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>W02060102</emdnCode>
    <emdnDescription>AUTOMATED SAMPLE TRANSPORT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU 8600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:53.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053033787</udiDi>
    <basicUdiDi>69449040AB4000002ZW</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay 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>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-2600i</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:51.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053022392</udiDi>
    <basicUdiDi>69449040AB3000008ZR</basicUdiDi>
    <tradeName>Auto Specific Protein and ESR  Analyzer</tradeName>
    <deviceName>Auto Specific Protein and ESR 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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP 200n</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:57.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053014854</udiDi>
    <basicUdiDi>69449040AB3000007ZP</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-700[B] CS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:18.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053011792</udiDi>
    <basicUdiDi>69449040AB3100002ZS</basicUdiDi>
    <tradeName>Urine Formed Element Analyzer</tradeName>
    <deviceName>Urine Formed Element 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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EH-2090B、EH-2090C、EH-2090B PRO、EH-2090C PRO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:12.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053011648</udiDi>
    <basicUdiDi>69449040AB3100003ZU</basicUdiDi>
    <tradeName>Automatic Dry Chemistry Urine Analyzer</tradeName>
    <deviceName>Automatic Dry Chemistry 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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-5600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:11.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053006415</udiDi>
    <basicUdiDi>69449040AB3000021ZH</basicUdiDi>
    <tradeName>Concentrated Reagent Delivery System</tradeName>
    <deviceName>Concentrated Reagent Delivery System</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>W02079002</emdnCode>
    <emdnDescription>DILUTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Concentrated Reagent Delivery System</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:05.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053004411</udiDi>
    <basicUdiDi>69449040AB3000006ZM</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-700[B]</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:46:54.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053000345</udiDi>
    <basicUdiDi>69449040AB3000025ZR</basicUdiDi>
    <tradeName>Sample Processing System</tradeName>
    <deviceName>Sample Processing System</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>W02060102</emdnCode>
    <emdnDescription>AUTOMATED SAMPLE TRANSPORT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL 7000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:46:39.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413814233</udiDi>
    <basicUdiDi>69444138H30ProSP9</basicUdiDi>
    <tradeName>Hematology Analyzer</tradeName>
    <deviceName>Hematology Analyzer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H30 Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:41:40.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413813366</udiDi>
    <basicUdiDi>69444138H60SPG</basicUdiDi>
    <tradeName>Hematology Analyzer</tradeName>
    <deviceName>Hematology Analyzer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:41:37.409Z</lastUpdated>
  </row>
</eudamedExport>