<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R20211Z9</udiDi>
    <basicUdiDi>B-R20211Z9</basicUdiDi>
    <tradeName>D-R20211Z9</tradeName>
    <deviceName>Vitamin B12 (Vit B12) 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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20211</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:00.746Z</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>08800111722905</udiDi>
    <basicUdiDi>88001117IPBA01IA18WA</basicUdiDi>
    <tradeName>STANDARD™ i Vitamin B12</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16VITB10F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:53:29.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS7200BP</udiDi>
    <basicUdiDi>B-MS7200BP</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum AUTOMATED  ON-LINE  with Filter-Plates</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS7200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:20.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS7100BJ</udiDi>
    <basicUdiDi>B-MS7100BJ</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum AUTOMATED  ON-LINE</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS7100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:19.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS7000BD</udiDi>
    <basicUdiDi>B-MS7000BD</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum ON-LINE</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS7000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:18.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS5100B4</udiDi>
    <basicUdiDi>B-MS5100B4</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit, advanced, for Methylmalonic Acid in Serum / Plasma / Urine</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>MS5100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:15:48.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS13000PD</udiDi>
    <basicUdiDi>B-MS13000PD</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit for Vitamins B1, B2 in Whole Blood and 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>W0102070399</emdnCode>
    <emdnDescription>MULTIPLE ANEMIA / VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS13000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:32.004Z</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-KR-25-OH-VD-05100DG</udiDi>
    <basicUdiDi>B-KR-25-OH-VD-05100DG</basicUdiDi>
    <tradeName>INNODX 25-OH-VD CMIA</tradeName>
    <deviceName>INNODX 25-OH-VD CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-25-OH-VD-05100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:40:35.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-25-OH-VD-0250XN</udiDi>
    <basicUdiDi>B-KR-25-OH-VD-0250XN</basicUdiDi>
    <tradeName>INNODX 25-OH-VD CMIA</tradeName>
    <deviceName>INNODX 25-OH-VD CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-25-OH-VD-0250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:40:31.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-25-OH-VD-02200CY</udiDi>
    <basicUdiDi>B-KR-25-OH-VD-02200CY</basicUdiDi>
    <tradeName>INNODX 25-OH-VD CMIA</tradeName>
    <deviceName>INNODX 25-OH-VD CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-25-OH-VD-02200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:40:30.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-25-OH-VD-01100CL</udiDi>
    <basicUdiDi>B-KR-25-OH-VD-01100CL</basicUdiDi>
    <tradeName>INNODX 25-OH-VD CMIA</tradeName>
    <deviceName>INNODX 25-OH-VD CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-25-OH-VD-01100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:40:29.561Z</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>
</eudamedExport>