<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00380740102715</udiDi>
    <basicUdiDi>B-00380740102715</basicUdiDi>
    <tradeName>00380740102715</tradeName>
    <deviceName>Theophylline</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000028203</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080402</emdnCode>
    <emdnDescription>THEOPHYLLINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5P06-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:46:08.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740102708</udiDi>
    <basicUdiDi>B-00380740102708</basicUdiDi>
    <tradeName>00380740102708</tradeName>
    <deviceName>Phenytoin</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000028203</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5P08-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:46:05.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740102692</udiDi>
    <basicUdiDi>B-00380740102692</basicUdiDi>
    <tradeName>00380740102692</tradeName>
    <deviceName>Phenobarbital</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000028203</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5P07-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:46:04.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740102685</udiDi>
    <basicUdiDi>B-00380740102685</basicUdiDi>
    <tradeName>00380740102685</tradeName>
    <deviceName>Carbamazepine</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000028203</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5P05-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:46:03.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740101220</udiDi>
    <basicUdiDi>B-00380740101220</basicUdiDi>
    <tradeName>00380740101220</tradeName>
    <deviceName>TDM Multiconstituent Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Scientific Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000028203</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5P04-21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:46:01.964Z</lastUpdated>
  </row>
</eudamedExport>