<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-6430030990745UJ</udiDi>
    <basicUdiDi>B-6430030990745UJ</basicUdiDi>
    <tradeName>Actim® CRP</tradeName>
    <deviceName>Actim® CRP</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31034ETPL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:43:13.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990127TJ</udiDi>
    <basicUdiDi>B-6430030990127TJ</basicUdiDi>
    <tradeName>Actim® CRP</tradeName>
    <deviceName>Actim® CRP</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31031ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:16.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5M28C2ZU</udiDi>
    <basicUdiDi>B-5M28C2ZU</basicUdiDi>
    <tradeName>Anti-Streptolysin O Test (FIA)</tradeName>
    <deviceName>Anti-Streptolysin O 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>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5M28C2-25-EU, 5M28C2-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:14.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5M24C2Z8</udiDi>
    <basicUdiDi>B-5M24C2Z8</basicUdiDi>
    <tradeName>Serum Amyloid A Test (FIA)</tradeName>
    <deviceName>Serum Amyloid A 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>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5M24C2-25-EU, 5M24C2-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:14.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5M20C2YL</udiDi>
    <basicUdiDi>B-5M20C2YL</basicUdiDi>
    <tradeName>Interleukin-6 Test (FIA)</tradeName>
    <deviceName>Interleukin-6 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>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5M20C2-25-EU, 5M20C2-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:09.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5M13C2YU</udiDi>
    <basicUdiDi>B-5M13C2YU</basicUdiDi>
    <tradeName>C-Reactive Protein Test (FIA)</tradeName>
    <deviceName>C-Reactive Protein 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>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5M13C2-25-EU, 5M13C2-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:02.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>08445982000853</udiDi>
    <basicUdiDi>B-08445982000853</basicUdiDi>
    <tradeName>Welleo CRP Professional Test</tradeName>
    <deviceName>Welleo CRP Professional Test</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:40:50.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974785750570</udiDi>
    <basicUdiDi>B-06974785750570</basicUdiDi>
    <tradeName>C reactive protein Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>C reactive protein Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCR-5013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:51.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-312024NBUL-207C</udiDi>
    <basicUdiDi>B-nvm-312024NBUL-207C</basicUdiDi>
    <tradeName>NADAL® CRP Quant Test</tradeName>
    <deviceName>CRP Quant Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>312024NBUL-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:13.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-311801N-20VR</udiDi>
    <basicUdiDi>B-nvm-311801N-20VR</basicUdiDi>
    <tradeName>NADAL® CRP Test</tradeName>
    <deviceName>CRP Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311801N-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:12.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID012H</udiDi>
    <basicUdiDi>B-VID012H</basicUdiDi>
    <tradeName>Whole C-Reactive Protein Test Kit (FIA)</tradeName>
    <deviceName>Whole C-Reactive Protein 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>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID01-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:42.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST0105D4</udiDi>
    <basicUdiDi>B-ST0105D4</basicUdiDi>
    <tradeName>hsCRP test kit (32 tests)</tradeName>
    <deviceName>hsCRP test kit (32 tests)</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0105</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:32:47.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST0103CY</udiDi>
    <basicUdiDi>B-ST0103CY</basicUdiDi>
    <tradeName>CRP with integrated capillary test kit (16 tests)</tradeName>
    <deviceName>CRP with integrated capillary test kit (16 tests)</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0103</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:32:46.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST0102CW</udiDi>
    <basicUdiDi>B-ST0102CW</basicUdiDi>
    <tradeName>CRP with integrated capillary test kit (32 tests)</tradeName>
    <deviceName>CRP with integrated capillary test kit (32 tests)</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:32:46.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST0100CS</udiDi>
    <basicUdiDi>B-ST0100CS</basicUdiDi>
    <tradeName>CRP test kit (32 tests)</tradeName>
    <deviceName>CRP test kit (32 tests)</deviceName>
    <manufacturerName>EUROLyser Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000013746</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:32:19.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAI2022006HU</udiDi>
    <basicUdiDi>B-SAI2022006HU</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>C-reactive protein Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAI2022006</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:25.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAI2022001HJ</udiDi>
    <basicUdiDi>B-SAI2022001HJ</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>C-reactive protein Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAI2022001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:05.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAA-D06aB3</udiDi>
    <basicUdiDi>B-SAA-D06aB3</basicUdiDi>
    <tradeName>SAA Test Kit FIA</tradeName>
    <deviceName>SAA 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>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAA -D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:43.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAA-D02aAP</udiDi>
    <basicUdiDi>B-SAA-D02aAP</basicUdiDi>
    <tradeName>SAA Rapid Test</tradeName>
    <deviceName>SAA Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAA-D02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:39.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCT/IL-6-D26a9Q</udiDi>
    <basicUdiDi>B-PCT/IL-6-D26a9Q</basicUdiDi>
    <tradeName>PCT/IL-6 Test Kit FIA</tradeName>
    <deviceName>PCT/IL-6 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>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCT/IL-6-D26a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:42:11.830Z</lastUpdated>
  </row>
</eudamedExport>