<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598110168</udiDi>
    <basicUdiDi>B-04050598110168</basicUdiDi>
    <tradeName>total sRANKL ELISA</tradeName>
    <deviceName>total sRANKL ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 1016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598123144</udiDi>
    <basicUdiDi>B-04050598123144</basicUdiDi>
    <tradeName>VDBP ELISA</tradeName>
    <deviceName>VDBP ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 2314</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169690172</udiDi>
    <basicUdiDi>5060169690172WR</basicUdiDi>
    <tradeName>Urine CartiLaps® (CTX-II) EIA</tradeName>
    <deviceName>Urine CartiLaps® (CTX-II) EIA</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-10F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:35.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169690059</udiDi>
    <basicUdiDi>5060169690059WU</basicUdiDi>
    <tradeName>Ostase® BAP EIA</tradeName>
    <deviceName>Ostase® BAP EIA</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-20F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:10.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590226558</udiDi>
    <basicUdiDi>150995901AccVitDDxRV</basicUdiDi>
    <tradeName>Access 25(OH) Vitamin D Total Reagent Pack</tradeName>
    <deviceName>Access 25(OH) Vitamin D Total Reagent Pack</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A98856</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:34:18.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590225964</udiDi>
    <basicUdiDi>150995901AccVitDA2ML</basicUdiDi>
    <tradeName>Access 25(OH) Vitamin D Total Reagent Pack</tradeName>
    <deviceName>Access 25(OH) Vitamin D Total Reagent Pack</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B24838</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:34:13.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854621435</udiDi>
    <basicUdiDi>B-06974854621435</basicUdiDi>
    <tradeName>Bone R-hydroxy Glutamic Acid Protein (BGP) Test</tradeName>
    <deviceName>Bone R-hydroxy Glutamic Acid Protein (BGP) Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2208925</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:57:06.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323019695</udiDi>
    <basicUdiDi>B-06974323019695</basicUdiDi>
    <tradeName>06974323019695</tradeName>
    <deviceName>Trypsinogen 2 Test Cassette (Lateral Flow Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:06:28.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323019688</udiDi>
    <basicUdiDi>B-06974323019688</basicUdiDi>
    <tradeName>06974323019688</tradeName>
    <deviceName>Trypsinogen 2 Test Cassette (Lateral Flow Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:06:26.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323019671</udiDi>
    <basicUdiDi>B-06974323019671</basicUdiDi>
    <tradeName>06974323019671</tradeName>
    <deviceName>Trypsinogen 2 Test Cassette (Lateral Flow Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:06:22.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719606948</udiDi>
    <basicUdiDi>B-06972719606948</basicUdiDi>
    <tradeName>06972719606948</tradeName>
    <deviceName>Beta-CrossLaps Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:54:18.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719606931</udiDi>
    <basicUdiDi>B-06972719606931</basicUdiDi>
    <tradeName>06972719606931</tradeName>
    <deviceName>Beta-CrossLaps Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:54:14.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719606924</udiDi>
    <basicUdiDi>B-06972719606924</basicUdiDi>
    <tradeName>06972719606924</tradeName>
    <deviceName>Beta-CrossLaps Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:54:14.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719606917</udiDi>
    <basicUdiDi>B-06972719606917</basicUdiDi>
    <tradeName>06972719606917</tradeName>
    <deviceName>Beta-CrossLaps Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:54:13.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719605972</udiDi>
    <basicUdiDi>B-06972719605972</basicUdiDi>
    <tradeName>06972719605972</tradeName>
    <deviceName>Beta-CrossLaps Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:51:22.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719605965</udiDi>
    <basicUdiDi>B-06972719605965</basicUdiDi>
    <tradeName>06972719605965</tradeName>
    <deviceName>Beta-CrossLaps Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:51:21.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008892</udiDi>
    <basicUdiDi>B-04050598008892</basicUdiDi>
    <tradeName>IDK® Osteoprotegerin ELISA</tradeName>
    <deviceName>IDK® Osteoprotegerin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 1017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:59.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000827</udiDi>
    <basicUdiDi>B-04050598000827</basicUdiDi>
    <tradeName>Osteoprotegerin (OPG) ELISA</tradeName>
    <deviceName>Osteoprotegerin (OPG) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 1011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:10.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590744397</udiDi>
    <basicUdiDi>150995901AccVitDDxRV</basicUdiDi>
    <tradeName>Access 25(OH) Vitamin D Total (Reagent Pack)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C28646</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:40:11.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028502446</udiDi>
    <basicUdiDi>B-06942028502446</basicUdiDi>
    <tradeName>Total type I Collagen Amino Terminal Lengthening Peptide(P1NP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Total type I Collagen Amino Terminal Lengthening Peptide(P1NP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060399</emdnCode>
    <emdnDescription>BONE METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DH0301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:45.690Z</lastUpdated>
  </row>
</eudamedExport>