<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000014455-BF-S213RJ</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S213RJ</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S213RJ</tradeName>
    <deviceName>IL-6 Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S213</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:52:47.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S212RG</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S212RG</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S212RG</tradeName>
    <deviceName>IL-6 Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S212</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:52:46.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S211RE</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S211RE</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S211RE</tradeName>
    <deviceName>IL-6 Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S211</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:52:46.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-83AQ</udiDi>
    <basicUdiDi>B-6-83AQ</basicUdiDi>
    <tradeName>D-6-83AQ</tradeName>
    <deviceName>Interluekin-6 (IL-6) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000069M, USIA00000070M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:23.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973224894189</udiDi>
    <basicUdiDi>6973224890076AT</basicUdiDi>
    <tradeName>06973224894189</tradeName>
    <deviceName>Unicorn-IL-6</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:08:20.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961668</udiDi>
    <basicUdiDi>0405686901393VS</basicUdiDi>
    <tradeName>IMMULITE 2000 IL2R</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_IL2R</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030607</emdnCode>
    <emdnDescription>INTERLEUKINS RECEPTORS (IL-2R,IL6R ...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381457</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:51.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414960982</udiDi>
    <basicUdiDi>0405686901394VU</basicUdiDi>
    <tradeName>IMMULITE 2000  IL-6</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_IL-6</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381452</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:36.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414953229</udiDi>
    <basicUdiDi>0405686901430V7</basicUdiDi>
    <tradeName>IMMULITE IL-10 Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_IL-10 Controls</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030608</emdnCode>
    <emdnDescription>CYTOKINES CALIBRATORS/CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385248</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:58.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414953151</udiDi>
    <basicUdiDi>0405686901424VC</basicUdiDi>
    <tradeName>IMMULITE Cytokine Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Cytokine Control Module</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030608</emdnCode>
    <emdnDescription>CYTOKINES CALIBRATORS/CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385389</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:51.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414622521</udiDi>
    <basicUdiDi>0405686901410UZ</basicUdiDi>
    <tradeName>IMMULITE 2000 TNFα</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_TNFα</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030603</emdnCode>
    <emdnDescription>TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11562388</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:39.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414622514</udiDi>
    <basicUdiDi>0405686901395VW</basicUdiDi>
    <tradeName>IMMULITE 2000 IL-8</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_IL-8</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030602</emdnCode>
    <emdnDescription>SOLUBLE ANTIGENS / RECEPTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11562389</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:38.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414622507</udiDi>
    <basicUdiDi>0405686901392VQ</basicUdiDi>
    <tradeName>IMMULITE 2000 IL-1β</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_IL-1β</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030601</emdnCode>
    <emdnDescription>INTERFERONS (α, β, ɣ…)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11562390</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:38.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414622491</udiDi>
    <basicUdiDi>0405686901391VN</basicUdiDi>
    <tradeName>IMMULITE 2000 IL-10</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_IL-10</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030604</emdnCode>
    <emdnDescription>TUMOUR NECROSIS FACTORS RECEPTORS (TNF-R I,TNF-R II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11562391</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:34.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>111761300821</udiDi>
    <basicUdiDi>PP07924LIOFERON0240</basicUdiDi>
    <tradeName>LIOFeron® TB/LTBI</tradeName>
    <deviceName>LIOFeron® HUMAN IFN-γ ELISA</deviceName>
    <manufacturerName>Lionex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030601</emdnCode>
    <emdnDescription>INTERFERONS (α, β, ɣ…)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LIOFeron 02_22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:35:31.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>111761298322</udiDi>
    <basicUdiDi>PP07924LIOFERON0122</basicUdiDi>
    <tradeName>LIOFeron® TB/LTBI</tradeName>
    <deviceName>LIOFeron® HUMAN BLOOD STIMULATION TUBES</deviceName>
    <manufacturerName>Lionex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000038504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030601</emdnCode>
    <emdnDescription>INTERFERONS (α, β, ɣ…)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LIOFeron 01_22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:35:27.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID052R</udiDi>
    <basicUdiDi>B-VID052R</basicUdiDi>
    <tradeName>Interleukin 6 Test Kit (FIA)</tradeName>
    <deviceName>Interleukin 6 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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID05-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:49.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-194A</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-194A</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-194A</tradeName>
    <deviceName>Interleukin-6 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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:55.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-002NZ</udiDi>
    <basicUdiDi>B-K90411-002NZ</basicUdiDi>
    <tradeName>D-K90411-002NZ</tradeName>
    <deviceName>Interleukin-6 (IL-6) 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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:36:46.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407302JL</udiDi>
    <basicUdiDi>B-IM4407302JL</basicUdiDi>
    <tradeName>D-IM4407302JL</tradeName>
    <deviceName>IL-6 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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407302</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:27.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406302JD</udiDi>
    <basicUdiDi>B-IM4406302JD</basicUdiDi>
    <tradeName>D-IM4406302JD</tradeName>
    <deviceName>IL-6 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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406302</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:27:26.798Z</lastUpdated>
  </row>
</eudamedExport>