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<eudamedExport entity="devices">
  <row>
    <udiDi>D-L89401G5V9</udiDi>
    <basicUdiDi>B-L89401G5V9</basicUdiDi>
    <tradeName>LIA-ANA-Profile</tradeName>
    <deviceName>LIA-ANA-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L89401G5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:48:37.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L89401G4-222</udiDi>
    <basicUdiDi>B-L89401G4-222</basicUdiDi>
    <tradeName>LIA-ANA-Profile</tradeName>
    <deviceName>LIA-ANA-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L89401G4-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:48:36.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L89401G3-2ZS</udiDi>
    <basicUdiDi>B-L89401G3-2ZS</basicUdiDi>
    <tradeName>LIA-ANA-Profile</tradeName>
    <deviceName>LIA-ANA-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L89401G3-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:48:36.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L89401G2-2ZM</udiDi>
    <basicUdiDi>B-L89401G2-2ZM</basicUdiDi>
    <tradeName>LIA-ANA-Profile</tradeName>
    <deviceName>LIA-ANA-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L89401G2-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:48:31.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L89401G1-2ZG</udiDi>
    <basicUdiDi>B-L89401G1-2ZG</basicUdiDi>
    <tradeName>LIA-ANA-Profile</tradeName>
    <deviceName>LIA-ANA-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L89401G1-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:48:30.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCAR-T402aXH</udiDi>
    <basicUdiDi>B-FDCAR-T402aXH</basicUdiDi>
    <tradeName>cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDCAR-T402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:44.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCAR-T402aHG92</udiDi>
    <basicUdiDi>B-FDCAR-T402aHG92</basicUdiDi>
    <tradeName>cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDCAR-T402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:43.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979878281467</udiDi>
    <basicUdiDi>B-06979878281467</basicUdiDi>
    <tradeName>06979878281467</tradeName>
    <deviceName>Cardiac Troponin I/N-terminal pro-Brain Natriuretic Peptide/D-Dimer Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001040</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:28.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979878281450</udiDi>
    <basicUdiDi>B-06979878281450</basicUdiDi>
    <tradeName>06979878281450</tradeName>
    <deviceName>Cardiac troponin I /Myoglobin/creatine kinase isoenzymes Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001039</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:24.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979878281399</udiDi>
    <basicUdiDi>B-06979878281399</basicUdiDi>
    <tradeName>06979878281399</tradeName>
    <deviceName>Cardiac Troponin I /Heart Type Fatty Acid Binding Protein Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001033</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:17.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979878281221</udiDi>
    <basicUdiDi>B-06979878281221</basicUdiDi>
    <tradeName>06979878281221</tradeName>
    <deviceName>C-peptide/insulinTest  (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001052</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:50:34.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896418367</udiDi>
    <basicUdiDi>B-06978896418367</basicUdiDi>
    <tradeName>PCT/hs-CRP+conventional CRP Combo Test Kit (Immunofluorescence Method)</tradeName>
    <deviceName>PCT/hs-CRP+conventional CRP Combo 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>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF-PCT-CRP-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:56:20.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896416073</udiDi>
    <basicUdiDi>B-06978896416073</basicUdiDi>
    <tradeName>06978896416073</tradeName>
    <deviceName>PCT/hs-CRP+conventional CRP Combo 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>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-PC-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:50:07.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896416066</udiDi>
    <basicUdiDi>B-06978896416066</basicUdiDi>
    <tradeName>06978896416066</tradeName>
    <deviceName>PCT/hs-CRP+conventional CRP Combo 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>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-PC-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:50:06.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896416059</udiDi>
    <basicUdiDi>B-06978896416059</basicUdiDi>
    <tradeName>06978896416059</tradeName>
    <deviceName>SAA/hs-CRP+conventional CRP Combo 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>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-SAA-CRP-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:50:05.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896416042</udiDi>
    <basicUdiDi>B-06978896416042</basicUdiDi>
    <tradeName>06978896416042</tradeName>
    <deviceName>SAA/hs-CRP+conventional CRP Combo 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>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-SAA-CRP-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:50:01.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896416035</udiDi>
    <basicUdiDi>B-06978896416035</basicUdiDi>
    <tradeName>06978896416035</tradeName>
    <deviceName>PGⅠ/PGⅡ Combo  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>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-PGⅠ-PGⅡ-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:50:00.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415618</udiDi>
    <basicUdiDi>B-06978896415618</basicUdiDi>
    <tradeName>06978896415618</tradeName>
    <deviceName>hs-cTnI/ CK-MB/ MYO Combo 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>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-Cardio3-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:29.319Z</lastUpdated>
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  <row>
    <udiDi>06978896415601</udiDi>
    <basicUdiDi>B-06978896415601</basicUdiDi>
    <tradeName>06978896415601</tradeName>
    <deviceName>hs-cTnI/ CK-MB/ MYO Combo 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>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-Cardio3-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:25.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977181060038</udiDi>
    <basicUdiDi>B-06977181060038</basicUdiDi>
    <tradeName>06977181060038</tradeName>
    <deviceName>Vascular Expansion Stimulating Phosphoprotein (VASP) Assay Kit</deviceName>
    <manufacturerName>PoonBio(Nanjing) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045245</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests / box,</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:26.313Z</lastUpdated>
  </row>
</eudamedExport>