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<eudamedExport entity="devices">
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    <udiDi>00847627012173</udiDi>
    <basicUdiDi>B-00847627012173</basicUdiDi>
    <tradeName>Caspase-3</tradeName>
    <deviceName>Caspase-3</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PP229AA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:42:38.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627007957</udiDi>
    <basicUdiDi>B-00847627007957</basicUdiDi>
    <tradeName>Caspase-3</tradeName>
    <deviceName>Caspase-3</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP229C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:25.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627007940</udiDi>
    <basicUdiDi>B-00847627007940</basicUdiDi>
    <tradeName>Caspase-3</tradeName>
    <deviceName>Caspase-3</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP229B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:25.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627007933</udiDi>
    <basicUdiDi>B-00847627007933</basicUdiDi>
    <tradeName>Caspase-3</tradeName>
    <deviceName>Caspase-3</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP229A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:24.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656825</udiDi>
    <basicUdiDi>B-00810173656825</basicUdiDi>
    <tradeName>In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)</tradeName>
    <deviceName>In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1CKMBB02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:09.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810173656818</udiDi>
    <basicUdiDi>B-00810173656818</basicUdiDi>
    <tradeName>In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)</tradeName>
    <deviceName>In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1CKMBB01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:08.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977805760245</udiDi>
    <basicUdiDi>697780576HSTAALIBMG6J</basicUdiDi>
    <tradeName>06977805760245</tradeName>
    <deviceName>Mycobacterium Multiplex-PCR Library Pre Kit</deviceName>
    <manufacturerName>Shenzhen Health SwifTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044339</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA05-01-24S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:52:06.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977805760214</udiDi>
    <basicUdiDi>697780576HSTAALIBMDK</basicUdiDi>
    <tradeName>06977805760214</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Health SwifTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044339</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA05-01-24S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:52:05.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904032269</udiDi>
    <basicUdiDi>69449040004JG6PD*******C3</basicUdiDi>
    <tradeName>Glucose-6-Phosphate Dehydrogenase (G6PD) Kit (UV Enzymatic Method)</tradeName>
    <deviceName>Glucose-6-Phosphate Dehydrogenase Kit  (UV Enzymatic Method)、G6PD 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002254-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:53:34.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904037431</udiDi>
    <basicUdiDi>69449040004ECHE********SY</basicUdiDi>
    <tradeName>Cholinesterase (CHE) Kit (DGKC Method)</tradeName>
    <deviceName>Cholinesterase (CHE) Kit (DGKC 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002162-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:44:09.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904037509</udiDi>
    <basicUdiDi>69449040004GLIP********EW</basicUdiDi>
    <tradeName>Lipase Kit (Enzymatic Colorimetric Assay Method)</tradeName>
    <deviceName>Lipase Kit (Enzymatic Colorimetric Assay 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002171-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:44:09.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904034959</udiDi>
    <basicUdiDi>694490400043AFU********F3</basicUdiDi>
    <tradeName>α-L-Fucosidase Kit (CNPF Method)</tradeName>
    <deviceName>α-L-Fucosidase Kit (CNPF Method)、AFU 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-003123-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:44:07.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904032207</udiDi>
    <basicUdiDi>69449040004JACE********SA</basicUdiDi>
    <tradeName>Angiotensin Converting Enzyme Kit  (Enzymatic Colorimetric Assay Method)</tradeName>
    <deviceName>Angiotensin Converting Enzyme Kit  (Enzymatic Colorimetric Assay Method)、ACE Calibrator、 ACE 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>W01010109</emdnCode>
    <emdnDescription>ANGIOTENSIN CONVERTING ENZYME (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002248-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:59.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904025261</udiDi>
    <basicUdiDi>694490400045CK-MB******U8</basicUdiDi>
    <tradeName>Creatine Kinase-MB Kit (IFCC Method)</tradeName>
    <deviceName>Creatine Kinase-MB Kit (IFCC Method)、CK-MB 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>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000870-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:43.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024752</udiDi>
    <basicUdiDi>694490400041a-HBDH*****EM</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase Kit (DGKC Method)</tradeName>
    <deviceName>α-Hydroxybutyrate Dehydrogenase Kit (DGKC 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000819-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:42:55.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024745</udiDi>
    <basicUdiDi>694490400041LDH********C9</basicUdiDi>
    <tradeName>Lactate Dehydrogenase Kit (IFCC Method)</tradeName>
    <deviceName>Lactate Dehydrogenase Kit (IFCC 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000818-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:42:50.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024738</udiDi>
    <basicUdiDi>694490400041GGT********JR</basicUdiDi>
    <tradeName>Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand)</tradeName>
    <deviceName>Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand)</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>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000817-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:42:50.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024721</udiDi>
    <basicUdiDi>694490400041ALP********EL</basicUdiDi>
    <tradeName>Alkaline phosphatase Kit (IFCC Modified Method)</tradeName>
    <deviceName>Alkaline phosphatase Kit (IFCC Modified 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000816-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:42:49.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024714</udiDi>
    <basicUdiDi>694490400041AST********PT</basicUdiDi>
    <tradeName>Aspartate Aminotransferase Kit (IFCC Method)</tradeName>
    <deviceName>Aspartate Aminotransferase Kit (IFCC 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000815-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:42:48.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024707</udiDi>
    <basicUdiDi>694490400041ALT********HG</basicUdiDi>
    <tradeName>Alanine Aminotransferase kit (IFCC Method)</tradeName>
    <deviceName>Alanine Aminotransferase kit (IFCC 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000814-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:42:44.207Z</lastUpdated>
  </row>
</eudamedExport>