<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00630414610849</udiDi>
    <basicUdiDi>0405686902345VN</basicUdiDi>
    <tradeName>Atellica CH Iron3 (Iron3)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Iron3</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070106</emdnCode>
    <emdnDescription>IRON (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:11.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414986210</udiDi>
    <basicUdiDi>0405686901379VY</basicUdiDi>
    <tradeName>IMMULITE 2000 EPO</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_EPO</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>W0102070101</emdnCode>
    <emdnDescription>ERYTHROPOIETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10487629</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:31.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768008085</udiDi>
    <basicUdiDi>0405686900881W5</basicUdiDi>
    <tradeName>N Latex Ferritin</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT _N_La_Ferr</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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:48.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768008054</udiDi>
    <basicUdiDi>0405686900964WA</basicUdiDi>
    <tradeName>N Latex sTfR</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_La_sTFR</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>W0102070104</emdnCode>
    <emdnDescription>SOLUBLE TRANSFERRIN RECEPTOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446127</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:43.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VOS01-01199</udiDi>
    <basicUdiDi>B-VOS01-01199</basicUdiDi>
    <tradeName>VivaDiag Plus Hemoglobin Test Strips</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>UNKNOWN</legislation>
    <emdnCode>W0102070105</emdnCode>
    <emdnDescription>RETICULOCYTE HAEMOGLOBIN CONTENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VOS01-011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:44.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID2835</udiDi>
    <basicUdiDi>B-VID2835</basicUdiDi>
    <tradeName>Ferritin Test Kit (FIA)</tradeName>
    <deviceName>Ferritin 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID28-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:29.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID129F5</udiDi>
    <basicUdiDi>B-VID129F5</basicUdiDi>
    <tradeName>VivaDiag Folate Test Kit (FIA)</tradeName>
    <deviceName>VivaDiag Folate 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>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID129-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:23.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-1542</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-1542</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-1542</tradeName>
    <deviceName>Ferritin 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:48.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-143Y</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-143Y</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-143Y</tradeName>
    <deviceName>Folate 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>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:48.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK019DT</udiDi>
    <basicUdiDi>B-SEK019DT</basicUdiDi>
    <tradeName>Folate Assay Kit (ECLIA)</tradeName>
    <deviceName>Folate Assay Kit (ECLIA)</deviceName>
    <manufacturerName>Jiangsu Sunlant Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025940</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:56.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1981546</udiDi>
    <basicUdiDi>B-R1981546</basicUdiDi>
    <tradeName>D-R1981546</tradeName>
    <deviceName>Ferritin (Fer) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R19815</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:59.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1981444</udiDi>
    <basicUdiDi>B-R1981444</basicUdiDi>
    <tradeName>D-R1981444</tradeName>
    <deviceName>Ferritin (Fer) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R19814</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:59.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1981342</udiDi>
    <basicUdiDi>B-R1981342</basicUdiDi>
    <tradeName>D-R1981342</tradeName>
    <deviceName>Ferritin (Fer) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R19813</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:54.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R198123Y</udiDi>
    <basicUdiDi>B-R198123Y</basicUdiDi>
    <tradeName>D-R198123Y</tradeName>
    <deviceName>Ferritin (Fer) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R19812</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:53.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R198113W</udiDi>
    <basicUdiDi>B-R198113W</basicUdiDi>
    <tradeName>D-R198113W</tradeName>
    <deviceName>Ferritin (Fer) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R19811</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:52.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Ferritin-01100CQW</udiDi>
    <basicUdiDi>B-KR-Ferritin-01100CQW</basicUdiDi>
    <tradeName>INNODX Ferritin CMIA</tradeName>
    <deviceName>INNODX Ferritin CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-Ferritin-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:43:39.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-026PF</udiDi>
    <basicUdiDi>B-K90411-026PF</basicUdiDi>
    <tradeName>D-K90411-026PF</tradeName>
    <deviceName>Ferritin 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:40.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K52-FERGS</udiDi>
    <basicUdiDi>B-K52-FERGS</basicUdiDi>
    <tradeName>BodyCheck Ferritin</tradeName>
    <deviceName>Ferritin Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811025/K52-FER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:36:39.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K01210VV</udiDi>
    <basicUdiDi>B-K01210VV</basicUdiDi>
    <tradeName>D-K01210VV</tradeName>
    <deviceName>Ferritin</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K01210</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:35:50.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408201JL</udiDi>
    <basicUdiDi>B-IM4408201JL</basicUdiDi>
    <tradeName>D-IM4408201JL</tradeName>
    <deviceName>Ferritin (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:48.940Z</lastUpdated>
  </row>
</eudamedExport>