<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-VID142S</udiDi>
    <basicUdiDi>B-VID142S</basicUdiDi>
    <tradeName>N-terminal Pro-brain Natriuretic Peptide Test Kit (FIA)</tradeName>
    <deviceName>N-terminal Pro-brain Natriuretic Peptide Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>VID14-03-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:54.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022027EJ</udiDi>
    <basicUdiDi>B-SAC2022027EJ</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>NT-proBNP N-terminal-pro-B-type natriuretic peptide Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>SAC2022027</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:42.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022026EG</udiDi>
    <basicUdiDi>B-SAC2022026EG</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>NT-proBNP N-terminal-pro-B-type natriuretic peptide Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>SAC2022026</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:42.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022025EE</udiDi>
    <basicUdiDi>B-SAC2022025EE</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>NT-proBNP N-terminal-pro-B-type natriuretic peptide Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>SAC2022025</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:42.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022006EA</udiDi>
    <basicUdiDi>B-SAC2022006EA</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>NT-proBNP N-terminal-pro-B-type natriuretic peptide Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>SAC2022006</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:53.569Z</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-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-FI-SNBNP-4028N</udiDi>
    <basicUdiDi>B-FI-SNBNP-4028N</basicUdiDi>
    <tradeName>D-FI-SNBNP-4028N</tradeName>
    <deviceName>High-Sensitivity NT-proBNP Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</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>High-Sensitivity NT-proBNP Test Cassette</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:28:22.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4103204EG</udiDi>
    <basicUdiDi>B-EIM4103204EG</basicUdiDi>
    <tradeName>D-EIM4103204EG</tradeName>
    <deviceName>N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4103204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:39.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4102204E9</udiDi>
    <basicUdiDi>B-EIM4102204E9</basicUdiDi>
    <tradeName>D-EIM4102204E9</tradeName>
    <deviceName>N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4102204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:34.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4101204E2</udiDi>
    <basicUdiDi>B-EIM4101204E2</basicUdiDi>
    <tradeName>D-EIM4101204E2</tradeName>
    <deviceName>N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Assay Kit by Fluorescence Immunochromatographic Method</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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4101204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:24.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BNP-D26aEA</udiDi>
    <basicUdiDi>B-BNP-D26aEA</basicUdiDi>
    <tradeName>BNP Test Kit FIA</tradeName>
    <deviceName>BNP 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>BNP-D26a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:28:22.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-CT-A111L9</udiDi>
    <basicUdiDi>B-ABT-CT-A111L9</basicUdiDi>
    <tradeName>Accu-Tell® NT-proBNP Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® NT-proBNP 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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-CT-A111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:19:43.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808170QH</udiDi>
    <basicUdiDi>B-808170QH</basicUdiDi>
    <tradeName>D-808170QH</tradeName>
    <deviceName>BNP 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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808170</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:07.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808166QS</udiDi>
    <basicUdiDi>B-808166QS</basicUdiDi>
    <tradeName>D-808166QS</tradeName>
    <deviceName>NT-proBNP 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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808166</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:00.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763419</udiDi>
    <basicUdiDi>B-15065023763419</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>NT-proBNP Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</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>TV20003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:35:13.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250834</udiDi>
    <basicUdiDi>B-08683548250834</basicUdiDi>
    <tradeName>RapidFor™ BNP Rapid Test Kit (FIA)</tradeName>
    <deviceName>BNP Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>VMPO45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:10:45.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250247</udiDi>
    <basicUdiDi>B-08683548250247</basicUdiDi>
    <tradeName>RapidFor™ NT-proBNP Rapid Test Kit (FIA)</tradeName>
    <deviceName>NT-proBNP Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>VMPO05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:30.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683347941605</udiDi>
    <basicUdiDi>B-08683347941605</basicUdiDi>
    <tradeName>RapidFor™ NT-proBNP Rapid Test Kit</tradeName>
    <deviceName>NT-proBNP 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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD54</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:05:00.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896416028</udiDi>
    <basicUdiDi>B-06978896416028</basicUdiDi>
    <tradeName>06978896416028</tradeName>
    <deviceName>B-type natriuretic peptide (BNP) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>W-IF2-BNP-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:59.902Z</lastUpdated>
  </row>
</eudamedExport>