<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-3026A6</udiDi>
    <basicUdiDi>B-3026A6</basicUdiDi>
    <tradeName>D-3026A6</tradeName>
    <deviceName>Folate in vitro diagnostic kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Aikang Diagnostics Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028962</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKBR3026030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:30.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3000-2334DB</udiDi>
    <basicUdiDi>B-3000-2334DB</basicUdiDi>
    <tradeName>sTfR (II)</tradeName>
    <deviceName>sTfR (II)</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070104</emdnCode>
    <emdnDescription>SOLUBLE TRANSFERRIN RECEPTOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-2334</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:06:23.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-28000FU</udiDi>
    <basicUdiDi>B-28000FU</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Vitamin C in Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070299</emdnCode>
    <emdnDescription>VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:28:11.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-27000FM</udiDi>
    <basicUdiDi>B-27000FM</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Chromatography Kit for Vitamin B1, B2, B6</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070399</emdnCode>
    <emdnDescription>MULTIPLE ANEMIA / VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:18:15.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-26000FE</udiDi>
    <basicUdiDi>B-26000FE</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Vitamin B6 in Plasma / Whole Blood</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070203</emdnCode>
    <emdnDescription>VITAMIN B6</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:05.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-25000F7</udiDi>
    <basicUdiDi>B-25000F7</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Vitamin B2 in Whole Blood</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070202</emdnCode>
    <emdnDescription>VITAMIN B2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:37.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-24000EY</udiDi>
    <basicUdiDi>B-24000EY</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Vitamin B1 in Whole Blood</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070201</emdnCode>
    <emdnDescription>VITAMIN B1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:38:17.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-22100EP</udiDi>
    <basicUdiDi>B-22100EP</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Vitamin A and E in Serum / Plasma by UHPLC</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070399</emdnCode>
    <emdnDescription>MULTIPLE ANEMIA / VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:27:45.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-22000EJ</udiDi>
    <basicUdiDi>B-22000EJ</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Vitamin A and E in Serum / Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070399</emdnCode>
    <emdnDescription>MULTIPLE ANEMIA / VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:27:44.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346403</udiDi>
    <basicUdiDi>B-20850076346403</basicUdiDi>
    <tradeName>Vitamin B12 Test Kit (CLIA)</tradeName>
    <deviceName>Vitamin B12 Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIVB12-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:03:27.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346397</udiDi>
    <basicUdiDi>B-20850076346397</basicUdiDi>
    <tradeName>Folate Test Kit (CLIA)</tradeName>
    <deviceName>Folate Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</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>CIFA-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:03:26.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346380</udiDi>
    <basicUdiDi>B-20850076346380</basicUdiDi>
    <tradeName>Ferritin Test Kit (CLIA)</tradeName>
    <deviceName>Ferritin Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</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>CIFER-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:03:25.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721376</udiDi>
    <basicUdiDi>692591270036H6</basicUdiDi>
    <tradeName>iFlash-Vitamin B12 II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86320</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723509</udiDi>
    <basicUdiDi>692591270035H4</basicUdiDi>
    <tradeName>iFlash-Ferritin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86008-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:14.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723530</udiDi>
    <basicUdiDi>692591270037H8</basicUdiDi>
    <tradeName>iFlash-Folate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86318</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:14.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245325</udiDi>
    <basicUdiDi>B-15065026245325</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Folic Acid Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20045</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:38:02.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245318</udiDi>
    <basicUdiDi>B-15065026245318</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Vitamin B12 Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20044</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:58.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245271</udiDi>
    <basicUdiDi>B-15065026245271</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Ferritin test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:52.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400783</udiDi>
    <basicUdiDi>B-14562185400783</basicUdiDi>
    <tradeName>14562185400783</tradeName>
    <deviceName>CL AIA-PACK Ferritin ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029236</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:22.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400752</udiDi>
    <basicUdiDi>B-14562185400752</basicUdiDi>
    <tradeName>14562185400752</tradeName>
    <deviceName>CL AIA-PACK Ferritin TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029136</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:17.602Z</lastUpdated>
  </row>
</eudamedExport>