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<eudamedExport entity="devices">
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    <basicUdiDi>5060169695986ZF</basicUdiDi>
    <tradeName>IDS Beta CrossLaps® (CTX-I)</tradeName>
    <deviceName>IDS  Beta CrossLaps® (CTX-I)</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>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-3000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:33:02.689Z</lastUpdated>
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  <row>
    <udiDi>05060169695283</udiDi>
    <basicUdiDi>5060169695283Y6</basicUdiDi>
    <tradeName>IDS-iSYS 25 VitDS</tradeName>
    <deviceName>IDS-iSYS 25 VitDS</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-2500N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:33:01.900Z</lastUpdated>
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    <udiDi>05060169690516</udiDi>
    <basicUdiDi>5060169690516X3</basicUdiDi>
    <tradeName>N-MID® Osteocalcin ELISA</tradeName>
    <deviceName>N-MID Osteocalcin ELISA</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>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-11F12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:37.068Z</lastUpdated>
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    <udiDi>05060169690455</udiDi>
    <basicUdiDi>5060169690455X8</basicUdiDi>
    <tradeName>25-Hydroxy Vitamin DS EIA</tradeName>
    <deviceName>25-Hydroxy Vitamin DS 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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-57SF1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:36.270Z</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>05060169690165</udiDi>
    <basicUdiDi>5060169690165WU</basicUdiDi>
    <tradeName>Alpha CrossLaps® (CTX-I) ELISA</tradeName>
    <deviceName>Alpha CrossLaps® (CTX-I) ELISA</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>W0102060317</emdnCode>
    <emdnDescription>PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-04F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:34.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169690134</udiDi>
    <basicUdiDi>5060169690134WH</basicUdiDi>
    <tradeName>Serum CrossLaps® (CTX-I) ELISA</tradeName>
    <deviceName>Serum CrossLaps® (CTX-I) ELISA</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>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-02F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:30.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169690097</udiDi>
    <basicUdiDi>5060169690097X4</basicUdiDi>
    <tradeName>1,25-Dihydroxy Vitamin D EIA</tradeName>
    <deviceName>1,25-Dihydroxy Vitamin D 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>W0102060308</emdnCode>
    <emdnDescription>1.25-DIHYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-62F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:29.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169690158</udiDi>
    <basicUdiDi>5060169690158WX</basicUdiDi>
    <tradeName>Urine BETA CrossLaps® (CTX-I) ELISA</tradeName>
    <deviceName>Urine BETA CrossLaps® (CTX-I) ELISA</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>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-05F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:29.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169690141</udiDi>
    <basicUdiDi>5060169690141WE</basicUdiDi>
    <tradeName>Urine CrossLaps® (CTX-I) EIA</tradeName>
    <deviceName>Urine CrossLaps® (CTX-I) 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>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-03F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:28.359Z</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>05060169690028</udiDi>
    <basicUdiDi>5060169690028WH</basicUdiDi>
    <tradeName>1,25-Dihydroxy Vitamin D RIA</tradeName>
    <deviceName>1,25-Dihydroxy Vitamin D RIA</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>W0102060308</emdnCode>
    <emdnDescription>1.25-DIHYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA-54F2</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:09.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157635296</udiDi>
    <basicUdiDi>426015763529BCalcitoRXXPU</basicUdiDi>
    <tradeName>B·R·A·H·M·S Calcitonin RIA</tradeName>
    <deviceName>B·R·A·H·M·S Calcitonin RIA</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>529.096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:35:02.641Z</lastUpdated>
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  <row>
    <udiDi>03701700807407</udiDi>
    <basicUdiDi>37017008VITD03FB</basicUdiDi>
    <tradeName>VITAMIN D</tradeName>
    <deviceName>VITAMIN D</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VITD-0250</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:49:57.869Z</lastUpdated>
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    <udiDi>03573026601560</udiDi>
    <basicUdiDi>357302BUDI000860U4</basicUdiDi>
    <tradeName>VIDAS® PTH (1-84)</tradeName>
    <deviceName>VIDAS® PTH (1-84)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>422010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:57:54.538Z</lastUpdated>
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    <udiDi>15099590213640</udiDi>
    <basicUdiDi>150995905IM111754</basicUdiDi>
    <tradeName>RIA cyclic AMP</tradeName>
    <deviceName>RIA cyclic AMP</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060306</emdnCode>
    <emdnDescription>CYCLIC ADENOSIN MONOPHOSPHATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM1117</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:43:29.496Z</lastUpdated>
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    <udiDi>15099590203719</udiDi>
    <basicUdiDi>150995905A44176SN</basicUdiDi>
    <tradeName>Ostase IRMA KIT</tradeName>
    <deviceName>Ostase IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060318</emdnCode>
    <emdnDescription>BONE ALKALINE PHOSPHATASE (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A44176</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:42:11.004Z</lastUpdated>
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    <udiDi>15099590201517</udiDi>
    <basicUdiDi>150995905PTHIRMAYZ</basicUdiDi>
    <tradeName>IRMA PTH</tradeName>
    <deviceName>IRMA PTH</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11930, B89461</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:41:38.927Z</lastUpdated>
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    <udiDi>15099590232313</udiDi>
    <basicUdiDi>150995901AccOstUS</basicUdiDi>
    <tradeName>Access Ostase Reagent Pack</tradeName>
    <deviceName>Access Ostase 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>W0102060318</emdnCode>
    <emdnDescription>BONE ALKALINE PHOSPHATASE (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37300</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:35:10.285Z</lastUpdated>
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    <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>
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