<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>06970417340324</udiDi>
    <basicUdiDi>69704173490.83.01.LF</basicUdiDi>
    <tradeName>Magnetic Immunoassay System</tradeName>
    <deviceName>Magnetic Immunoassay System</deviceName>
    <manufacturerName>Shenzhen BOSH Diagnostics, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012412</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>m16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:11:30.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970417340072</udiDi>
    <basicUdiDi>69704173490.83.08.M4</basicUdiDi>
    <tradeName>Colloidal Gold-labeled Immunoassay System</tradeName>
    <deviceName>Colloidal Gold-labeled Immunoassay System</deviceName>
    <manufacturerName>Shenzhen BOSH Diagnostics, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012412</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:11:28.268Z</lastUpdated>
  </row>
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