<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-5J12C1XL</udiDi>
    <basicUdiDi>B-5J12C1XL</basicUdiDi>
    <tradeName>sST2 Test (FIA)</tradeName>
    <deviceName>sST2 Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5J12C1-25-EU, 5J12C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:59.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5J11C1XF</udiDi>
    <basicUdiDi>B-5J11C1XF</basicUdiDi>
    <tradeName>Myeloperoxidase Test (FIA)</tradeName>
    <deviceName>Myeloperoxidase Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5J11C1-25-EU, 5J11C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:55.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST2-D06aFG</udiDi>
    <basicUdiDi>B-ST2-D06aFG</basicUdiDi>
    <tradeName>ST2 Test Kit FIA</tradeName>
    <deviceName>ST2 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>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST2-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:43:45.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HFABP-W23F3ZP</udiDi>
    <basicUdiDi>B-HFABP-W23F3ZP</basicUdiDi>
    <tradeName>D-HFABP-W23F3ZP</tradeName>
    <deviceName>H-FABP FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-FABP-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:54:28.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMC-W23SG</udiDi>
    <basicUdiDi>B-CMC-W23SG</basicUdiDi>
    <tradeName>D-CMC-W23SG</tradeName>
    <deviceName>Cardiac Marker Rapid Test device and Immunoassay Reader</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMC-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:08:48.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMC-W23FBK</udiDi>
    <basicUdiDi>B-CMC-W23FBK</basicUdiDi>
    <tradeName>D-CMC-W23FBK</tradeName>
    <deviceName>Cardiac Marker Combo Rapid Test Device and Fluorescent Immunoassay Reader</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMC-W23F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:08:47.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-CT-A251LS</udiDi>
    <basicUdiDi>B-ABT-CT-A251LS</basicUdiDi>
    <tradeName>Accu-Tell® CRP Test Semi-Quantitative Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® CRP Test Semi-Quantitative Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-A251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:19:47.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>86979834610337</udiDi>
    <basicUdiDi>B-86979834610337</basicUdiDi>
    <tradeName>Cardiac Injury Marker Test Device (Serum/plasma/whole  blood)</tradeName>
    <deviceName>Cardiac Injury Marker Test Device (Serum/plasma/whole  blood)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR0239</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:22:31.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808169QY</udiDi>
    <basicUdiDi>B-808169QY</basicUdiDi>
    <tradeName>D-808169QY</tradeName>
    <deviceName>CK-MB Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808169</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:06.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683347941612</udiDi>
    <basicUdiDi>B-08683347941612</basicUdiDi>
    <tradeName>RapidFor™ Myo + CK-MB + Troponin I Combo Rapid Test Kit</tradeName>
    <deviceName>Myo + CK-MB + Troponin I Combo Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD55</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:05:08.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683347941575</udiDi>
    <basicUdiDi>B-08683347941575</basicUdiDi>
    <tradeName>RapidFor™ CK-MB Rapid Test Kit</tradeName>
    <deviceName>CK-MB Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD51</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:04:58.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141953</udiDi>
    <basicUdiDi>B-06977194141953</basicUdiDi>
    <tradeName>06977194141953</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0508003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:13:16.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141946</udiDi>
    <basicUdiDi>B-06977194141946</basicUdiDi>
    <tradeName>06977194141946</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0508002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:13:15.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141939</udiDi>
    <basicUdiDi>B-06977194141939</basicUdiDi>
    <tradeName>06977194141939</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0508001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:13:14.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141717</udiDi>
    <basicUdiDi>B-06977194141717</basicUdiDi>
    <tradeName>06977194141717</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0201901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:24.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804825867</udiDi>
    <basicUdiDi>B-06952804825867</basicUdiDi>
    <tradeName>06952804825867</tradeName>
    <deviceName>NT-ProBNP Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G112A08X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:34.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804825843</udiDi>
    <basicUdiDi>B-06952804825843</basicUdiDi>
    <tradeName>06952804825843</tradeName>
    <deviceName>High-sensitive Cardiac Troponin I Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G104A08X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:29.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581432016</udiDi>
    <basicUdiDi>B-06970581432016</basicUdiDi>
    <tradeName>Accu-Tell® CRP Semi-Quantitative Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® CRP Test Semi-Quantitative Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-B251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:48:23.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804810788</udiDi>
    <basicUdiDi>B-06952804810788</basicUdiDi>
    <tradeName>Cardiac Troponin I Rapid Test Device (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Cardiac Troponin I Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRO-W23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:27:04.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020141352</udiDi>
    <basicUdiDi>B-06936020141352</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>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD110-02-20t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:11:32.968Z</lastUpdated>
  </row>
</eudamedExport>