<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975984064130</udiDi>
    <basicUdiDi>69703416803205090JN</basicUdiDi>
    <tradeName>H-FABP STAT (eCLIA)</tradeName>
    <deviceName>H-FABP STAT (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:03:37.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063898</udiDi>
    <basicUdiDi>69703416803205095JY</basicUdiDi>
    <tradeName>HS-CRP STAT (eCLIA)</tradeName>
    <deviceName>HS-CRP STAT (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:03:35.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145589134</udiDi>
    <basicUdiDi>69471455643WP</basicUdiDi>
    <tradeName>Biossays Myeloperoxidase (Latex Immunoturbidimetric)</tradeName>
    <deviceName>Myeloperoxidase (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W01021310</emdnCode>
    <emdnDescription>MYELOPEROXIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130504013S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:43:06.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145557201</udiDi>
    <basicUdiDi>69471455635WQ</basicUdiDi>
    <tradeName>Biossays High Sensitivity C-Reactive Protein (Latex Immunoturbidimetric)</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130504012S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:39.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145555689</udiDi>
    <basicUdiDi>69471455606WH</basicUdiDi>
    <tradeName>Biossays Myoglobin (Latex Immunoturbidimetric)</tradeName>
    <deviceName>Myoglobin (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130504010A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:35.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145551568</udiDi>
    <basicUdiDi>69471455625WM</basicUdiDi>
    <tradeName>Biossays Heart-type Fatty Acid-Binding Protein (Latex Immunoturbidimetric)</tradeName>
    <deviceName>Heart-type Fatty Acid-Binding Protein (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130504011S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:31.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145541552</udiDi>
    <basicUdiDi>69471455186WG</basicUdiDi>
    <tradeName>MAGLUMI sST2 (CLIA)</tradeName>
    <deviceName>sST2 (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W01021314</emdnCode>
    <emdnDescription>ST2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130606022M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:19.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595301612</udiDi>
    <basicUdiDi>4987595PF1061KXK</basicUdiDi>
    <tradeName>PATHFAST NTproBNP</tradeName>
    <deviceName>PATHFAST NTproBNP</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30161</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:56.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595301315</udiDi>
    <basicUdiDi>4987595PF1031KX4</basicUdiDi>
    <tradeName>PATHFAST CK-MB</tradeName>
    <deviceName>PATHFAST CK-MB</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30131</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:51.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595301216</udiDi>
    <basicUdiDi>4987595PF1021KWX</basicUdiDi>
    <tradeName>PATHFAST Myo</tradeName>
    <deviceName>PATHFAST Myo</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30121</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:50.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595301179</udiDi>
    <basicUdiDi>4987595PF1241KXP</basicUdiDi>
    <tradeName>PATHFAST hs-cTnI</tradeName>
    <deviceName>PATHFAST hs-cTnI</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30117</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:46.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595301117</udiDi>
    <basicUdiDi>4987595PF1011KWS</basicUdiDi>
    <tradeName>PATHFAST cTnI</tradeName>
    <deviceName>PATHFAST cTnI</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30111</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:44.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414599304</udiDi>
    <basicUdiDi>0405686901615VM</basicUdiDi>
    <tradeName>Atellica IM Homocysteine (HCY)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995607</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:47:02.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414284927</udiDi>
    <basicUdiDi>0405686902296W2</basicUdiDi>
    <tradeName>ADVIA Centaur NT‑proBNPII (PBNPII)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_KIT_PBNPII</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11203759</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:42.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414228945</udiDi>
    <basicUdiDi>0405686901817W3</basicUdiDi>
    <tradeName>Atellica IM NT-proBNP (PBNP)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_PBNP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11200588</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:22.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414177434</udiDi>
    <basicUdiDi>0405686901804VS</basicUdiDi>
    <tradeName>ADVIA Centaur® CKMB</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_CKMB</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10309982</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:32:49.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768029929</udiDi>
    <basicUdiDi>0405686901272VD</basicUdiDi>
    <tradeName>Dimension EXL N-terminal Pro-Brain Natriuretic Peptide Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_LNTP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10464338</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:48.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768013843</udiDi>
    <basicUdiDi>0405686901284VL</basicUdiDi>
    <tradeName>Dimension Myoglobin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_MYO</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444907</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:28.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768013829</udiDi>
    <basicUdiDi>0405686901279VT</basicUdiDi>
    <tradeName>Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Mass Creatine Kinase MB</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444904</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:11.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005657</udiDi>
    <basicUdiDi>0405686901207V2</basicUdiDi>
    <tradeName>Dimension Triglycerides Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_TRIG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444906</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:58.524Z</lastUpdated>
  </row>
</eudamedExport>