<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-WO-VD-C41-2565</udiDi>
    <basicUdiDi>B-WO-VD-C41-2565</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Vitamin D Rapid Test Cassette</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WO-VD-C41-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:34.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID74-FH</udiDi>
    <basicUdiDi>B-VID74-FH</basicUdiDi>
    <tradeName>Parathyroid Hormone Test Kit</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>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID74- 05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:24.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID2937</udiDi>
    <basicUdiDi>B-VID2937</basicUdiDi>
    <tradeName>25-Hydroxyvitamin D3 (25-OH-D3) Test Kit (FIA)</tradeName>
    <deviceName>25-Hydroxyvitamin D3 (25-OH-D3) 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>W0102060308</emdnCode>
    <emdnDescription>1.25-DIHYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID29-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:33.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-133W</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-133W</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-133W</tradeName>
    <deviceName>25-hydroxy Vitamin D 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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:47.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK018DR</udiDi>
    <basicUdiDi>B-SEK018DR</basicUdiDi>
    <tradeName>25-OH-VD Assay Kit (ECLIA)</tradeName>
    <deviceName>25-OH-VD 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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:55.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK017DP</udiDi>
    <basicUdiDi>B-SEK017DP</basicUdiDi>
    <tradeName>PTH Assay Kit (ECLIA)</tradeName>
    <deviceName>PTH 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>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:54.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK016DM</udiDi>
    <basicUdiDi>B-SEK016DM</basicUdiDi>
    <tradeName>β-cTx Assay Kit (ECLIA)</tradeName>
    <deviceName>β-cTx 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>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:50.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK015DK</udiDi>
    <basicUdiDi>B-SEK015DK</basicUdiDi>
    <tradeName>Osteocalcin Assay Kit (ECLIA)</tradeName>
    <deviceName>Osteocalcin 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>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:49.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAI2022016HX</udiDi>
    <basicUdiDi>B-SAI2022016HX</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>25-hydroxy vitamin D Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAI2022016</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:39.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAI2022015HV</udiDi>
    <basicUdiDi>B-SAI2022015HV</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>25-hydroxy vitamin D Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAI2022015</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:38.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAI2022004HQ</udiDi>
    <basicUdiDi>B-SAI2022004HQ</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>25-hydroxy vitamin D Determination Kit（Fluorescence Immunochromatographic Assay）</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAI2022004</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:24.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111725098</udiDi>
    <basicUdiDi>88001117IPBA01IA17W8</basicUdiDi>
    <tradeName>STANDARD™ i Vitamin D Total</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16VITD10F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:56:54.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111725104</udiDi>
    <basicUdiDi>88001117IPBA01IA17W8</basicUdiDi>
    <tradeName>STANDARD™ i Vitamin D Total</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16VITD10Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:56:54.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PTH706-AE8N</udiDi>
    <basicUdiDi>B-PTH706-AE8N</basicUdiDi>
    <tradeName>PTH Parathyroid Hormone (CLIA)</tradeName>
    <deviceName>PTH Parathyroid Hormone (CLIA)</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>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTH706-AE10Y, PTH706-AE10N, PTH706-AE20Y, PTH706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T14:12:52.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-CT-0250TR</udiDi>
    <basicUdiDi>B-KR-CT-0250TR</basicUdiDi>
    <tradeName>INNODX CT CMIA</tradeName>
    <deviceName>INNODX CT 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-CT-0250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:35.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-CT-02200M6</udiDi>
    <basicUdiDi>B-KR-CT-02200M6</basicUdiDi>
    <tradeName>INNODX CT CMIA</tradeName>
    <deviceName>INNODX CT 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-CT-02200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:34.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-CT-01100LS</udiDi>
    <basicUdiDi>B-KR-CT-01100LS</basicUdiDi>
    <tradeName>INNODX CT CMIA</tradeName>
    <deviceName>INNODX CT 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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-CT-01100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:33.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-030P6</udiDi>
    <basicUdiDi>B-K90411-030P6</basicUdiDi>
    <tradeName>D-K90411-030P6</tradeName>
    <deviceName>25-hydroxyvitamin D (25-OH VD) 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>W0102060308</emdnCode>
    <emdnDescription>1.25-DIHYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:46.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408351K8</udiDi>
    <basicUdiDi>B-IM4408351K8</basicUdiDi>
    <tradeName>D-IM4408351K8</tradeName>
    <deviceName>25-OH Vitamin D Chemiluminescent Immunoassay Kit</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:30:22.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4408060JS</udiDi>
    <basicUdiDi>B-IM4408060JS</basicUdiDi>
    <tradeName>D-IM4408060JS</tradeName>
    <deviceName>Calcitonin (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>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:41.555Z</lastUpdated>
  </row>
</eudamedExport>