<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04712803532256</udiDi>
    <basicUdiDi>B-04712803532256</basicUdiDi>
    <tradeName>ANTISURASE B-96 II (TMB)</tradeName>
    <deviceName>ANTISURASE B-96 II (TMB)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020203</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4SBE6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:36.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712803531150</udiDi>
    <basicUdiDi>B-04712803531150</basicUdiDi>
    <tradeName>ANTISURASE B-96 (TMB)</tradeName>
    <deviceName>ANTISURASE B-96 (TMB)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020203</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4SBE3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:09.389Z</lastUpdated>
  </row>
</eudamedExport>