<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975424221482</udiDi>
    <basicUdiDi>B-06975424221482</basicUdiDi>
    <tradeName>Anti-streptolysin O Assay Kit（Fluorescence Immunoassay）</tradeName>
    <deviceName>Anti-streptolysin O Assay Kit（Fluorescence Immunoassay）</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:41.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974849366211</udiDi>
    <basicUdiDi>B-06974849366211</basicUdiDi>
    <tradeName>Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus</tradeName>
    <deviceName>Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-UR010A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:13.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023767</udiDi>
    <basicUdiDi>8488380BDrpDesoxychocZ6</basicUdiDi>
    <tradeName>BACTIDROP DESOXYCHOLATE (10%)</tradeName>
    <deviceName>BACTIDROP DESOXYCHOLATE</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21508</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:42.917Z</lastUpdated>
  </row>
</eudamedExport>