<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-TD-HNKX-CED-1644</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-1644</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-1644</tradeName>
    <deviceName>Serum Amyloid A Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:52.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RheumatoidFactor3Z</udiDi>
    <basicUdiDi>B-RheumatoidFactor3Z</basicUdiDi>
    <tradeName>Rheumatoid Factor (RA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Ra-Ma-050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:33:31.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RFIgM7J</udiDi>
    <basicUdiDi>B-RFIgM7J</basicUdiDi>
    <tradeName>RF IgM (CLIA)</tradeName>
    <deviceName>RF IgM (CLIA)</deviceName>
    <manufacturerName>DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED</manufacturerName>
    <manufacturerSrn>CN-MF-000042193</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/kit: (Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:27.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RF601WC</udiDi>
    <basicUdiDi>B-RF601WC</basicUdiDi>
    <tradeName>Rheumatoid Factor Reagent Kit</tradeName>
    <deviceName>Rheumatoid Factor Reagent Kit</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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RF6011Y, RF6012Y, RF6013Y, RF6014Y, RF6015Y, RF6011N, RF6012N, RF6013N, RF6014N, RF6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:25.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PA000455</udiDi>
    <basicUdiDi>B-PA000455</basicUdiDi>
    <tradeName>C-Reactive Protein (CRP) Detection Kit (Nephelometry)</tradeName>
    <deviceName>C-Reactive Protein (CRP) Detection Kit (Nephelometry)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32026009</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:32:10.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PA000353</udiDi>
    <basicUdiDi>B-PA000353</basicUdiDi>
    <tradeName>C-Reactive Protein (CRP)Detection Kit(Nephelometry)</tradeName>
    <deviceName>C-Reactive Protein (CRP)Detection Kit(Nephelometry)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32080009</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:32:09.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K91201-074E</udiDi>
    <basicUdiDi>B-K91201-074E</basicUdiDi>
    <tradeName>D-K91201-074E</tradeName>
    <deviceName>Serum Amyloid A (SAA) Protein Assay Kit (Nephelometry)</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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:40.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K91201-054A</udiDi>
    <basicUdiDi>B-K91201-054A</basicUdiDi>
    <tradeName>D-K91201-054A</tradeName>
    <deviceName>Full Range C-reactive Protein (FR-CRP) Assay Kit (Nephelometry)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:36.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K91201-0142</udiDi>
    <basicUdiDi>B-K91201-0142</basicUdiDi>
    <tradeName>D-K91201-0142</tradeName>
    <deviceName>C-reactive Protein (CRP) Assay Kit (Nephelometry)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:30.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-007PB</udiDi>
    <basicUdiDi>B-K90411-007PB</basicUdiDi>
    <tradeName>D-K90411-007PB</tradeName>
    <deviceName>Serum Amyloid A  (SAA) 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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:36:54.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-006P9</udiDi>
    <basicUdiDi>B-K90411-006P9</basicUdiDi>
    <tradeName>D-K90411-006P9</tradeName>
    <deviceName>Full C-reactive protein  (CRP) 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:36:53.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4492022LB</udiDi>
    <basicUdiDi>B-IM4492022LB</basicUdiDi>
    <tradeName>D-IM4492022LB</tradeName>
    <deviceName>Serum amyloid A 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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4492022</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:13.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4491022L4</udiDi>
    <basicUdiDi>B-IM4491022L4</basicUdiDi>
    <tradeName>D-IM4491022L4</tradeName>
    <deviceName>Serum amyloid A 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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4491022</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:35.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4415271JX</udiDi>
    <basicUdiDi>B-IM4415271JX</basicUdiDi>
    <tradeName>D-IM4415271JX</tradeName>
    <deviceName>RF-IgA 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415271</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:34:36.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4415270JV</udiDi>
    <basicUdiDi>B-IM4415270JV</basicUdiDi>
    <tradeName>D-IM4415270JV</tradeName>
    <deviceName>RF-IgM 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415270</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:34:35.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4415269KC</udiDi>
    <basicUdiDi>B-IM4415269KC</basicUdiDi>
    <tradeName>D-IM4415269KC</tradeName>
    <deviceName>RF-IgG 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415269</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:34:34.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4415268KA</udiDi>
    <basicUdiDi>B-IM4415268KA</basicUdiDi>
    <tradeName>D-IM4415268KA</tradeName>
    <deviceName>RF 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415268</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:34:30.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4414271JQ</udiDi>
    <basicUdiDi>B-IM4414271JQ</basicUdiDi>
    <tradeName>D-IM4414271JQ</tradeName>
    <deviceName>RF-IgA 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414271</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:33:49.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4414270JN</udiDi>
    <basicUdiDi>B-IM4414270JN</basicUdiDi>
    <tradeName>D-IM4414270JN</tradeName>
    <deviceName>RF-IgM 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414270</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:33:45.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4414269K5</udiDi>
    <basicUdiDi>B-IM4414269K5</basicUdiDi>
    <tradeName>D-IM4414269K5</tradeName>
    <deviceName>RF-IgG 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414269</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:33:44.911Z</lastUpdated>
  </row>
</eudamedExport>