<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850004812402</udiDi>
    <basicUdiDi>B-00850004812402</basicUdiDi>
    <tradeName>NORFENTANYL 50ng/mL 2x5mL KITBOX</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>702016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:44.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812389</udiDi>
    <basicUdiDi>B-00850004812389</basicUdiDi>
    <tradeName>STAT-SKREEN WITH MDMA, OXY, &amp; BUP, 2x5mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>702014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:42.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812372</udiDi>
    <basicUdiDi>B-00850004812372</basicUdiDi>
    <tradeName>STAT-SKREEN 17H, 2x10mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>702004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:27.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812365</udiDi>
    <basicUdiDi>B-00850004812365</basicUdiDi>
    <tradeName>DOA SKREEN-H 2x10mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>702002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:26.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812341</udiDi>
    <basicUdiDi>B-00850004812341</basicUdiDi>
    <tradeName>SERIES XV-H  CUTOFF +25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19601058-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:25.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812334</udiDi>
    <basicUdiDi>B-00850004812334</basicUdiDi>
    <tradeName>SERIES XV-H  CUTOFF -25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19601057-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:21.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812327</udiDi>
    <basicUdiDi>B-00850004812327</basicUdiDi>
    <tradeName>SERIES VI  CUTOFF +25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19466756-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:20.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812310</udiDi>
    <basicUdiDi>B-00850004812310</basicUdiDi>
    <tradeName>SERIES VI  CUTOFF -25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19466252-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:20.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812303</udiDi>
    <basicUdiDi>B-00850004812303</basicUdiDi>
    <tradeName>SERIES V CUTOFF -25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19458252-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:19.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812297</udiDi>
    <basicUdiDi>B-00850004812297</basicUdiDi>
    <tradeName>SERIES V CUTOFF +25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19458756-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:15.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812280</udiDi>
    <basicUdiDi>B-00850004812280</basicUdiDi>
    <tradeName>SERIES IV  CUTOFF +25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19447756-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:14.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812273</udiDi>
    <basicUdiDi>B-00850004812273</basicUdiDi>
    <tradeName>SERIES IV CUTOFF -25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19447252-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:13.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812266</udiDi>
    <basicUdiDi>B-00850004812266</basicUdiDi>
    <tradeName>SERIES III CUTOFF +25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19437756-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:12.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812259</udiDi>
    <basicUdiDi>B-00850004812259</basicUdiDi>
    <tradeName>SERIES III CUTOFF -25% 6x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19437252-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:08.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812242</udiDi>
    <basicUdiDi>B-00850004812242</basicUdiDi>
    <tradeName>HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX</tradeName>
    <deviceName>PREGNANCY-SKREEN hCG LIQUID CONTROLS</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>702013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:08.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812235</udiDi>
    <basicUdiDi>B-00850004812235</basicUdiDi>
    <tradeName>COTININE URINE CONTROL 2x5mL Kitbox</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>702018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:07.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812228</udiDi>
    <basicUdiDi>B-00850004812228</basicUdiDi>
    <tradeName>GC/MS-H CUTOFF 10x50mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19572502-10pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:06.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812211</udiDi>
    <basicUdiDi>B-00850004812211</basicUdiDi>
    <tradeName>GC/MS CUTOFF</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19330000-10pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:02.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812204</udiDi>
    <basicUdiDi>B-00850004812204</basicUdiDi>
    <tradeName>CONFIRM 4, Cutoff -60%, 10x50mL</tradeName>
    <deviceName>DETECTABUSE LIQUID CONTROL URINE</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19582041-10pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:01.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812198</udiDi>
    <basicUdiDi>B-00850004812198</basicUdiDi>
    <tradeName>ETHYL GLUCURONIDE 1000 ng/mL 2x20mL</tradeName>
    <deviceName>Detectabuse Liquid Control Urine</deviceName>
    <manufacturerName>Biochemical Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000025179</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19900100-2pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:00.801Z</lastUpdated>
  </row>
</eudamedExport>