<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850004812556</udiDi>
    <basicUdiDi>B-00850004812556</basicUdiDi>
    <tradeName>SERIES X-H, 3X CUTOFF, 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>19601908-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:53:08.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812549</udiDi>
    <basicUdiDi>B-00850004812549</basicUdiDi>
    <tradeName>SERIES XV-H  3X CUTOFF 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>19601059-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:53:05.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812532</udiDi>
    <basicUdiDi>B-00850004812532</basicUdiDi>
    <tradeName>ETHYL GLUCURONIDE 500ng/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>19900050-2pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:53:04.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812525</udiDi>
    <basicUdiDi>B-00850004812525</basicUdiDi>
    <tradeName>ETHYL GLUCURONIDE 250ng/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>19900025-2pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:53:03.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812518</udiDi>
    <basicUdiDi>B-00850004812518</basicUdiDi>
    <tradeName>Negative Urine Control 6x10mL</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>19000010-6PK</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:53:01.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812495</udiDi>
    <basicUdiDi>B-00850004812495</basicUdiDi>
    <tradeName>STAT-SKREEN17H URINE POSITIVE CONTROL, 6x10mL</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>19003081-6PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:59.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812488</udiDi>
    <basicUdiDi>B-00850004812488</basicUdiDi>
    <tradeName>STAT-SKREEN17 POSITIVE CONTROL, 6x10mL</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>19003066-6PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:57.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812471</udiDi>
    <basicUdiDi>B-00850004812471</basicUdiDi>
    <tradeName>DOA-SKREEN-H POSITIVE CONTROL, 6x10mL</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>19003030-6PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:56.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812464</udiDi>
    <basicUdiDi>B-00850004812464</basicUdiDi>
    <tradeName>DOA-SKREEN POSITIVE CONTROL, 6x10mL</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>19003020-6PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:55.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812457</udiDi>
    <basicUdiDi>B-00850004812457</basicUdiDi>
    <tradeName>STAT-SKREEN-H with MDMA, OXY &amp; BUP, POSITIVE CONTROL 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>19002081-6PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:52.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812440</udiDi>
    <basicUdiDi>B-00850004812440</basicUdiDi>
    <tradeName>STAT-SKREEN with MDMA, OXY &amp; BUP, POSITIVE CONTROL 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>19002066-6PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:51.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812433</udiDi>
    <basicUdiDi>B-00850004812433</basicUdiDi>
    <tradeName>STAT-SKREEN-H with MDMA, OXY &amp; BUP, POSITIVE CONTROL 10x5ML</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>19001081-10PK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:50.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812426</udiDi>
    <basicUdiDi>B-00850004812426</basicUdiDi>
    <tradeName>STAT-SKREEN-H with MDMA, OXY &amp; BUP 2x20mL 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>702029</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:48.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812396</udiDi>
    <basicUdiDi>B-00850004812396</basicUdiDi>
    <tradeName>STAT-SKREEN-H 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>702015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:46.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812419</udiDi>
    <basicUdiDi>B-00850004812419</basicUdiDi>
    <tradeName>STAT-SKREEN with MDMA, OXY &amp; BUP 2x20ML 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>702028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:52:44.882Z</lastUpdated>
  </row>
  <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>
</eudamedExport>