<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06977100860091</udiDi>
    <basicUdiDi>697710086ASTMYN9</basicUdiDi>
    <tradeName>Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90</tradeName>
    <deviceName>Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90</deviceName>
    <manufacturerName>Suzhou Astrabio Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041763</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8901000100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:09:43.641Z</lastUpdated>
  </row>
</eudamedExport>