<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00630414978161</udiDi>
    <basicUdiDi>0405686901398W4</basicUdiDi>
    <tradeName>IMMULITE 2000 LBP</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_KIT_LBP</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381474</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:25.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414972916</udiDi>
    <basicUdiDi>0405686901405V8</basicUdiDi>
    <tradeName>IMMULITE 2000 SHBG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_Sex hormone-binding globulin</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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381198</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:01.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414962214</udiDi>
    <basicUdiDi>0405686901414V9</basicUdiDi>
    <tradeName>IMMULITE 2000 Total Testosterone</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_Total Testosterone</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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:35.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961989</udiDi>
    <basicUdiDi>0405686901401UY</basicUdiDi>
    <tradeName>IMMULITE 2000 Progesterone</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_Progestrne</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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381170</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:09.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961934</udiDi>
    <basicUdiDi>0405686901402V2</basicUdiDi>
    <tradeName>IMMULITE 2000 Prolactin</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_Prolctn</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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:06.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768037634</udiDi>
    <basicUdiDi>0405686900879WJ</basicUdiDi>
    <tradeName>N Latex BTP</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT _N_La_BTP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10709757</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:54.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768037351</udiDi>
    <basicUdiDi>0405686900986WL</basicUdiDi>
    <tradeName>N Latex Cystatin C</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT _Na_La_CYS_C</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10709554</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:51.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768012938</udiDi>
    <basicUdiDi>0405686900892WA</basicUdiDi>
    <tradeName>N a1-Microglobulin Kit</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT_N_a1-MIC_Kit</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446619</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:33.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768011498</udiDi>
    <basicUdiDi>0405686900944W4</basicUdiDi>
    <tradeName>N Antiserum to Human Fibronectin</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_AS_FibNec</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446462</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:15.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768009877</udiDi>
    <basicUdiDi>0405686900952W3</basicUdiDi>
    <tradeName>N Antiserum to Human a1-acid Glycoprotein</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_AS_a1-aG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:02.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-a2-MG601AB</udiDi>
    <basicUdiDi>B-a2-MG601AB</basicUdiDi>
    <tradeName>α₂-Macroglobulin Reagent Kit</tradeName>
    <deviceName>α₂-Macroglobulin 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>α2-MG6011Y, α2-MG6012Y, α2-MG6013Y, α2-MG6014Y, α2-MG6015Y, α2-MG6011N, α2-MG6012N, α2-MG6013N, α2-MG6014N, α2-MG6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:04.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-a1-MG6019S</udiDi>
    <basicUdiDi>B-a1-MG6019S</basicUdiDi>
    <tradeName>α₁-Microglobulin Reagent Kit</tradeName>
    <deviceName>α₁-Microglobulin 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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>α1-MG6011Y, α1-MG6012Y, α1-MG6013Y, α1-MG6014Y, α1-MG6015Y, α1-MG6011N, α1-MG6012N, α1-MG6013N, α1-MG6014N, α1-MG6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:18:55.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID144EZ</udiDi>
    <basicUdiDi>B-VID144EZ</basicUdiDi>
    <tradeName>Beta Amyloid 40 Test Kit (FIA)</tradeName>
    <deviceName></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>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID144-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:57.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID137F4</udiDi>
    <basicUdiDi>B-VID137F4</basicUdiDi>
    <tradeName>Myxovirus Resistance Protein A Test Kit (FIA)</tradeName>
    <deviceName></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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID137-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:43.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID042P</udiDi>
    <basicUdiDi>B-VID042P</basicUdiDi>
    <tradeName>Serum Amyloid A Protein Test Kit (FIA)</tradeName>
    <deviceName>Serum Amyloid A 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID04-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:48.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID032M</udiDi>
    <basicUdiDi>B-VID032M</basicUdiDi>
    <tradeName>Cystatin C Test Kit (FIA)</tradeName>
    <deviceName>Cystatin C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID03-02-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:48.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-6149</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-6149</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-6149</tradeName>
    <deviceName>Calprotectin 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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:34.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-3446</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-3446</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-3446</tradeName>
    <deviceName>Placental Alpha-1-microglobulin 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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:36.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-3344</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-3344</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-3344</tradeName>
    <deviceName>Fetal Fibronectin 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:33.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SL80-LPVG</udiDi>
    <basicUdiDi>B-SL80-LPVG</basicUdiDi>
    <tradeName>D-SL80-LPVG</tradeName>
    <deviceName>Lipoprotein electrophoresis kit 80 tests</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-80-LP</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:30:50.516Z</lastUpdated>
  </row>
</eudamedExport>