<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-K90411-023P9</udiDi>
    <basicUdiDi>B-K90411-023P9</basicUdiDi>
    <tradeName>D-K90411-023P9</tradeName>
    <deviceName>Lipoprotein associated phospholipase A2 (Lp-PLA2) Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:34.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-020P3</udiDi>
    <basicUdiDi>B-K90411-020P3</basicUdiDi>
    <tradeName>D-K90411-020P3</tradeName>
    <deviceName>Cardiac Troponin I &amp; Creatine kinase Isoenzyme MB &amp; Myoglobin Combo Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:29.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-018PG</udiDi>
    <basicUdiDi>B-K90411-018PG</basicUdiDi>
    <tradeName>D-K90411-018PG</tradeName>
    <deviceName>N-terminal pro-B-type Natriuretic Peptide &amp;Cardiac Troponin I Combo Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:27.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-008PD</udiDi>
    <basicUdiDi>B-K90411-008PD</basicUdiDi>
    <tradeName>D-K90411-008PD</tradeName>
    <deviceName>Creatine kinase Isoenzyme MB(CK-MB) Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:36:55.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4495158MS</udiDi>
    <basicUdiDi>B-IM4495158MS</basicUdiDi>
    <tradeName>D-IM4495158MS</tradeName>
    <deviceName>BNP Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4495158</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:37:50.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4494158MK</udiDi>
    <basicUdiDi>B-IM4494158MK</basicUdiDi>
    <tradeName>D-IM4494158MK</tradeName>
    <deviceName>BNP Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4494158</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:37:30.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4493158MC</udiDi>
    <basicUdiDi>B-IM4493158MC</basicUdiDi>
    <tradeName>D-IM4493158MC</tradeName>
    <deviceName>BNP Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4493158</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:50.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4493157MA</udiDi>
    <basicUdiDi>B-IM4493157MA</basicUdiDi>
    <tradeName>D-IM4493157MA</tradeName>
    <deviceName>High Sensitive Troponin T Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4493157</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:49.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4493156M8</udiDi>
    <basicUdiDi>B-IM4493156M8</basicUdiDi>
    <tradeName>D-IM4493156M8</tradeName>
    <deviceName>High Sensitive Troponin I Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4493156</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:48.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4492157M3</udiDi>
    <basicUdiDi>B-IM4492157M3</basicUdiDi>
    <tradeName>D-IM4492157M3</tradeName>
    <deviceName>High Sensitive Troponin T Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4492157</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:23.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4492156LZ</udiDi>
    <basicUdiDi>B-IM4492156LZ</basicUdiDi>
    <tradeName>D-IM4492156LZ</tradeName>
    <deviceName>High Sensitive Troponin I Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4492156</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:22.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4491157LU</udiDi>
    <basicUdiDi>B-IM4491157LU</basicUdiDi>
    <tradeName>D-IM4491157LU</tradeName>
    <deviceName>High Sensitive Troponin T Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4491157</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:45.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4491156LS</udiDi>
    <basicUdiDi>B-IM4491156LS</basicUdiDi>
    <tradeName>D-IM4491156LS</tradeName>
    <deviceName>High Sensitive Troponin I Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4491156</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:43.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408154K4</udiDi>
    <basicUdiDi>B-IM4408154K4</basicUdiDi>
    <tradeName>D-IM4408154K4</tradeName>
    <deviceName>NT-proBNP (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408154</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:48.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408153K2</udiDi>
    <basicUdiDi>B-IM4408153K2</basicUdiDi>
    <tradeName>D-IM4408153K2</tradeName>
    <deviceName>cTnI (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408153</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:47.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408152JY</udiDi>
    <basicUdiDi>B-IM4408152JY</basicUdiDi>
    <tradeName>D-IM4408152JY</tradeName>
    <deviceName>CK-MB (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408152</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:46.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408151JW</udiDi>
    <basicUdiDi>B-IM4408151JW</basicUdiDi>
    <tradeName>D-IM4408151JW</tradeName>
    <deviceName>MYO (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:42.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407303JN</udiDi>
    <basicUdiDi>B-IM4407303JN</basicUdiDi>
    <tradeName>D-IM4407303JN</tradeName>
    <deviceName>hs-CRP Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407303</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:27.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407158K5</udiDi>
    <basicUdiDi>B-IM4407158K5</basicUdiDi>
    <tradeName>D-IM4407158K5</tradeName>
    <deviceName>BNP Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407158</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:46.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407157K3</udiDi>
    <basicUdiDi>B-IM4407157K3</basicUdiDi>
    <tradeName>D-IM4407157K3</tradeName>
    <deviceName>High Sensitive Troponin T Chemiluminescent Immunoassay kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407157</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:43.901Z</lastUpdated>
  </row>
</eudamedExport>