<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06976667950054</udiDi>
    <basicUdiDi>697666795FIC-H3TJ</basicUdiDi>
    <tradeName>Bio-INSTANT</tradeName>
    <deviceName>FIC-H3</deviceName>
    <manufacturerName>Hangzhou ELIT Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043511</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-H3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:53:08.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976667950030</udiDi>
    <basicUdiDi>697666795DOAZ8</basicUdiDi>
    <tradeName>Multi-Drug Rapid Test 14 Drugs in 1 Combo Panel (OPI2000/MDMA500/MOP300/OXY100/MTD300/PCP25/COC300/AMP1000/MET1000/BAR300/EDDP100/THC50/BZO300/BUP10)</tradeName>
    <deviceName>Multi-Drug Rapid Test 14 Drugs in 1 Combo Panel (OPI2000/MDMA500/MOP300/OXY100/MTD300/PCP25/COC300/AMP1000/MET1000/BAR300/EDDP100/THC50/BZO300/BUP10)</deviceName>
    <manufacturerName>Hangzhou ELIT Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043511</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDOA-124~1144</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:53:07.930Z</lastUpdated>
  </row>
</eudamedExport>