<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04250317524362</udiDi>
    <basicUdiDi>B-04250317524362</basicUdiDi>
    <tradeName>MassTox® TDM Series A PARAMETER-Set  Tricyclic Antidepressants TCA 2 in Serum/Plasma</tradeName>
    <deviceName>MassTox® TDM Series A PARAMETER Set Tricyclic Antidepressants TCA 2 in Serum/Plasma</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92920</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:43:09.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524355</udiDi>
    <basicUdiDi>B-04250317524355</basicUdiDi>
    <tradeName>Tuning Mix</tradeName>
    <deviceName>Tuning Mix</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:43:09.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524348</udiDi>
    <basicUdiDi>B-04250317524348</basicUdiDi>
    <tradeName>MassCheck® Tricyclic Antidepressants TCA 2 
Plasma Control, Bi-Level (I + II)</tradeName>
    <deviceName>MassCheck® Tricyclic Antidepressants TCA 2 Plasma Control, Bi-Level (I + II)</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0246</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:43:08.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524331</udiDi>
    <basicUdiDi>B-04250317524331</basicUdiDi>
    <tradeName>MassCheck® Tricyclic Antidepressants TCA 2 
Plasma Control, Level II</tradeName>
    <deviceName>MassCheck® Tricyclic Antidepressants TCA 2 Plasma Control, Level II</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0248</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:43:08.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524300</udiDi>
    <basicUdiDi>B-04250317524300</basicUdiDi>
    <tradeName>Tuning Mix</tradeName>
    <deviceName>Tuning Mix</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:43:03.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524324</udiDi>
    <basicUdiDi>B-04250317524324</basicUdiDi>
    <tradeName>MassCheck® Tricyclic Antidepressants TCA 2 
Plasma Control, Level I</tradeName>
    <deviceName>MassCheck® Tricyclic Antidepressants TCA 2 Plasma Control, Level I</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0247</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:43:02.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524317</udiDi>
    <basicUdiDi>B-04250317524317</basicUdiDi>
    <tradeName>MassTox® TDM Series A PARAMETER-Set  Tricyclic Antidepressants TCA 1 in Serum/Plasma</tradeName>
    <deviceName>MassTox® TDM Series A PARAMETER Set Tricyclic Antidepressants TCA 1 in Serum/Plasma</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92919</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:43:02.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524294</udiDi>
    <basicUdiDi>B-04250317524294</basicUdiDi>
    <tradeName>MassCheck® Tricyclic Antidepressants TCA 1 Plasma Control, Bi-Level (I + II)</tradeName>
    <deviceName>MassCheck® Tricyclic Antidepressants TCA 1 Plasma Control, Bi-Level (I + II)</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:43:02.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524263</udiDi>
    <basicUdiDi>B-04250317524263</basicUdiDi>
    <tradeName>MassTox® TDM Series A PARAMETER-Set  Benzodiazepines 2 in Serum/Plasma</tradeName>
    <deviceName>MassTox® TDM Series A PARAMETER Set Benzodiazepines 2 in Serum/Plasma</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92918</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:55.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524256</udiDi>
    <basicUdiDi>B-04250317524256</basicUdiDi>
    <tradeName>Tuning Mix</tradeName>
    <deviceName>Tuning Mix</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:54.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524287</udiDi>
    <basicUdiDi>B-04250317524287</basicUdiDi>
    <tradeName>MassCheck® Tricyclic Antidepressans TCA 1 Plasma Control, Level II</tradeName>
    <deviceName>MassCheck® Tricyclic Antidepressants TCA 1 Plasma Control, Level II</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0245</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:53.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524270</udiDi>
    <basicUdiDi>B-04250317524270</basicUdiDi>
    <tradeName>MassCheck® Tricyclic Antidepressants TCA 1 Plasma Control, Level I</tradeName>
    <deviceName>MassCheck® Tricyclic Antidepressants TCA 1 Plasma Control, Level I</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0244</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:53.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524232</udiDi>
    <basicUdiDi>B-04250317524232</basicUdiDi>
    <tradeName>MassCheck® Benzodiazepines 2 Plasma Control, Bi-Level (I + II)</tradeName>
    <deviceName>MassCheck® Benzodiazepines 2 Plasma Control, Bi-Level (I + II)</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:34.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524249</udiDi>
    <basicUdiDi>B-04250317524249</basicUdiDi>
    <tradeName>Tuning Mix</tradeName>
    <deviceName>Tuning Mix</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:33.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524225</udiDi>
    <basicUdiDi>B-04250317524225</basicUdiDi>
    <tradeName>MassCheck® Benzodiazepines 2 Plasma Control, Level II</tradeName>
    <deviceName>MassCheck® Benzodiazepines 2 Plasma Control, Level II</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0242</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:33.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524201</udiDi>
    <basicUdiDi>B-04250317524201</basicUdiDi>
    <tradeName>MassCheck® Benzodiazepines 2 Plasma Control, Level I</tradeName>
    <deviceName>MassCheck® Benzodiazepines 2 Plasma Control, Level I</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:32.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524171</udiDi>
    <basicUdiDi>B-04250317524171</basicUdiDi>
    <tradeName>MassTox® TDM Series A PARAMETER-Set Benzodiazepines 1 in Serum/Plasma</tradeName>
    <deviceName>MassTox® TDM Series A PARAMETER Set Benzodiazepines 1 in Serum/Plasma</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92917</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:28.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524164</udiDi>
    <basicUdiDi>B-04250317524164</basicUdiDi>
    <tradeName>MassCheck® Benzodiazepines 1 Plasma Control, Bi-Level (I + II)</tradeName>
    <deviceName>MassCheck® Benzodiazepines 1 Plasma Control, Bi-Level (I + II)</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0237</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:25.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524157</udiDi>
    <basicUdiDi>B-04250317524157</basicUdiDi>
    <tradeName>MassCheck® Benzodiazepines 1 Plasma Control, Level II</tradeName>
    <deviceName>MassCheck® Benzodiazepines 1 Plasma Control, Level II</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0239</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:23.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250317524140</udiDi>
    <basicUdiDi>B-04250317524140</basicUdiDi>
    <tradeName>MassCheck® Benzodiazepines 1 Plasma Control, Level I</tradeName>
    <deviceName>MassCheck® Benzodiazepines 1 Plasma Control, Level I</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0238</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:22.621Z</lastUpdated>
  </row>
</eudamedExport>