<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>00630414622514</udiDi>
    <basicUdiDi>0405686901395VW</basicUdiDi>
    <tradeName>IMMULITE 2000 IL-8</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_IL-8</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030602</emdnCode>
    <emdnDescription>SOLUBLE ANTIGENS / RECEPTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11562389</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:38.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974524061561</udiDi>
    <basicUdiDi>B-06974524061561</basicUdiDi>
    <tradeName>Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Krebs von den Lungen 6 (KL-6) Test Kit (Homogeneous Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Nanjing Poclight Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039609</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030602</emdnCode>
    <emdnDescription>SOLUBLE ANTIGENS / RECEPTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCLIA15132</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:49:06.029Z</lastUpdated>
  </row>
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