<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810042683242</udiDi>
    <basicUdiDi>B-00810042683242</basicUdiDi>
    <tradeName>SSHMOBE with Butalbital Cutoff +50%, 20mL</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>18008327</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:51.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042683235</udiDi>
    <basicUdiDi>B-00810042683235</basicUdiDi>
    <tradeName>SSHMOBE with Butalbital Cutoff -50%, 20mL</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>18002824</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:49.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042683211</udiDi>
    <basicUdiDi>B-00810042683211</basicUdiDi>
    <tradeName>CSCQ Specimen 3</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>18008447</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:47.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042683204</udiDi>
    <basicUdiDi>B-00810042683204</basicUdiDi>
    <tradeName>CSCQ Specimen 2</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18008446</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:34.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042683198</udiDi>
    <basicUdiDi>B-00810042683198</basicUdiDi>
    <tradeName>CSCQ Specimen 1</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>18008445</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:31.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042683181</udiDi>
    <basicUdiDi>B-00810042683181</basicUdiDi>
    <tradeName>HCG URINE CONTROL Negative/Low Positive 2x4mL</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>702012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:30.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042683174</udiDi>
    <basicUdiDi>B-00810042683174</basicUdiDi>
    <tradeName>hCG Low positive / Negative URINE 2x5mL 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>18003155</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:29.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042683167</udiDi>
    <basicUdiDi>B-00810042683167</basicUdiDi>
    <tradeName>PREGNANCY-SKREEN  hCG Liquid Control Serum -/+ 2x4mL</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>702033</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:27.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042683150</udiDi>
    <basicUdiDi>B-00810042683150</basicUdiDi>
    <tradeName>PREGNANCY-SKREEN  hCG Liquid Control Serum -/+  Low Positive 2x4mL</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>702032</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:25.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042683075</udiDi>
    <basicUdiDi>B-00810042683075</basicUdiDi>
    <tradeName>SSHMOBE with BUTALBITAL 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>820001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:23.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682986</udiDi>
    <basicUdiDi>B-00810042682986</basicUdiDi>
    <tradeName>THC 1000ng, 100mL</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>18000454</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:23.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682979</udiDi>
    <basicUdiDi>B-00810042682979</basicUdiDi>
    <tradeName>AUNZS19 Cutoff +50%, 20mL</tradeName>
    <deviceName>SALIVABUSE LIQUID CONTROL ORAL FLUID</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>18100157</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:21.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682955</udiDi>
    <basicUdiDi>B-00810042682955</basicUdiDi>
    <tradeName>AUNZS19 Cutoff -50%, 20mL</tradeName>
    <deviceName>SALIVABUSE LIQUID CONTROL ORAL FLUID</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>18100156</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:19.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682931</udiDi>
    <basicUdiDi>B-00810042682931</basicUdiDi>
    <tradeName>SSHMOBE with Butalbital 3X 100mL</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>18008284</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:19.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682870</udiDi>
    <basicUdiDi>B-00810042682870</basicUdiDi>
    <tradeName>STAT-SKREEN Cutoff, 20mL</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>19470056</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:16.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682863</udiDi>
    <basicUdiDi>B-00810042682863</basicUdiDi>
    <tradeName>CONFIRM 3, Cutoff -25%, 50mL</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>19582025</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:15.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682856</udiDi>
    <basicUdiDi>B-00810042682856</basicUdiDi>
    <tradeName>GCMS-H Control, Cutoff -60%, 50mL</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>19572256</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:11.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682849</udiDi>
    <basicUdiDi>B-00810042682849</basicUdiDi>
    <tradeName>SERIES IV-H, Cutoff +25%, 20mL</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>19544756</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:11.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682832</udiDi>
    <basicUdiDi>B-00810042682832</basicUdiDi>
    <tradeName>SERIES IV-H, Cutoff -25%, 20 mL</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>19544252</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:10.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810042682825</udiDi>
    <basicUdiDi>B-00810042682825</basicUdiDi>
    <tradeName>SERIES IX 3X Cutoff, 20mL</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>19499908</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:09.433Z</lastUpdated>
  </row>
</eudamedExport>