<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09120132230036</udiDi>
    <basicUdiDi>1912013223A290-012VR</basicUdiDi>
    <tradeName>09120132230036</tradeName>
    <deviceName>Control-Set: (DBS Control-Set – Level I, II, III for Lyso Triplex)</deviceName>
    <manufacturerName>ARCHImedline GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000037501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A290-012</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-26T15:08:33.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120132230029</udiDi>
    <basicUdiDi>1912013223A290-011VP</basicUdiDi>
    <tradeName>09120132230029</tradeName>
    <deviceName>Calibrator-Set: (DBS Calibrator-Set – Level 0-6 for Lyso Triplex)</deviceName>
    <manufacturerName>ARCHImedline GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000037501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A290-011</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-26T15:08:32.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120132230012</udiDi>
    <basicUdiDi>1912013223A290EL</basicUdiDi>
    <tradeName>09120132230012</tradeName>
    <deviceName>Lyso Triplex</deviceName>
    <manufacturerName>ARCHImedline GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000037501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A290</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-26T15:08:31.562Z</lastUpdated>
  </row>
</eudamedExport>