<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-OGGDTRO-402bZH</udiDi>
    <basicUdiDi>B-OGGDTRO-402bZH</basicUdiDi>
    <tradeName>Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDTRO-402b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:12:22.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NT-proBNP-D06a9N</udiDi>
    <basicUdiDi>B-NT-proBNP-D06a9N</basicUdiDi>
    <tradeName>NT-proBNP Test Kit FIA</tradeName>
    <deviceName>NT-proBNP Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT-proBNP-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:07:17.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MYO-D06aRX</udiDi>
    <basicUdiDi>B-MYO-D06aRX</basicUdiDi>
    <tradeName>MYO Test Kit FIA</tradeName>
    <deviceName>MYO Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYO-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:33.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-010NY</udiDi>
    <basicUdiDi>B-K90411-010NY</basicUdiDi>
    <tradeName>D-K90411-010NY</tradeName>
    <deviceName>Myoglobin (Myo) 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>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:15.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-009PF</udiDi>
    <basicUdiDi>B-K90411-009PF</basicUdiDi>
    <tradeName>D-K90411-009PF</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) 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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:09.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-003P3</udiDi>
    <basicUdiDi>B-K90411-003P3</basicUdiDi>
    <tradeName>D-K90411-003P3</tradeName>
    <deviceName>N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) 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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:36:48.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVD83-02-50tDY</udiDi>
    <basicUdiDi>B-IVD83-02-50tDY</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD83-02-50t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:34.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVD83-02-30tDN</udiDi>
    <basicUdiDi>B-IVD83-02-30tDN</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD83-02-30t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:33.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVD83-02-25tDY</udiDi>
    <basicUdiDi>B-IVD83-02-25tDY</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD83-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:32.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVD83-02-20tDH</udiDi>
    <basicUdiDi>B-IVD83-02-20tDH</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD83-02-20t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:30.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVD83-02-10tDC</udiDi>
    <basicUdiDi>B-IVD83-02-10tDC</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD83-02-10t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:27.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVD83-02-100tAQ</udiDi>
    <basicUdiDi>B-IVD83-02-100tAQ</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD83-02-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:26.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4106203H3</udiDi>
    <basicUdiDi>B-IM4106203H3</basicUdiDi>
    <tradeName>D-IM4106203H3</tradeName>
    <deviceName>Myoglobin (MYO) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4106203</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:48.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4106202GZ</udiDi>
    <basicUdiDi>B-IM4106202GZ</basicUdiDi>
    <tradeName>D-IM4106202GZ</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4106202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:47.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4106201GX</udiDi>
    <basicUdiDi>B-IM4106201GX</basicUdiDi>
    <tradeName>D-IM4106201GX</tradeName>
    <deviceName>Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4106201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:46.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4105203GU</udiDi>
    <basicUdiDi>B-IM4105203GU</basicUdiDi>
    <tradeName>D-IM4105203GU</tradeName>
    <deviceName>Myoglobin (MYO) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4105203</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:45.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4105202GS</udiDi>
    <basicUdiDi>B-IM4105202GS</basicUdiDi>
    <tradeName>D-IM4105202GS</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4105202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:41.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4105201GQ</udiDi>
    <basicUdiDi>B-IM4105201GQ</basicUdiDi>
    <tradeName>D-IM4105201GQ</tradeName>
    <deviceName>Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4105201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:41.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4104203GM</udiDi>
    <basicUdiDi>B-IM4104203GM</basicUdiDi>
    <tradeName>D-IM4104203GM</tradeName>
    <deviceName>Myoglobin (MYO) Assay Kit by Fluorescence Immunochromatographic Metho</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>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4104203</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:39.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4104202GK</udiDi>
    <basicUdiDi>B-IM4104202GK</basicUdiDi>
    <tradeName>D-IM4104202GK</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4104202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:39.033Z</lastUpdated>
  </row>
</eudamedExport>