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<eudamedExport entity="devices">
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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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>06942028502484</udiDi>
    <basicUdiDi>B-06942028502484</basicUdiDi>
    <tradeName>Bone Alkaline Phosphatase (BAP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Bone Alkaline Phosphatase (BAP) 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>W0102060318</emdnCode>
    <emdnDescription>BONE ALKALINE PHOSPHATASE (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DH0401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:48.089Z</lastUpdated>
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