<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08720726199377</udiDi>
    <basicUdiDi>8720726199CellVision3W</basicUdiDi>
    <tradeName>CellVision, 20 micron, Sperm Counting Grid (Makler)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Attain Technologies B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000020626</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV 1020-102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:39:15.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720726199384</udiDi>
    <basicUdiDi>8720726199CellVision3W</basicUdiDi>
    <tradeName>CellVision, 20 micron, Post Vasectomy Grid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Attain Technologies B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000020626</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV 1020-PV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:39:15.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720726199391</udiDi>
    <basicUdiDi>8720726199CellVision3W</basicUdiDi>
    <tradeName>CellVision, 100 micron, Neubauer improved</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Attain Technologies B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000020626</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV 1100-NI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:39:15.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720726199407</udiDi>
    <basicUdiDi>8720726199CellVision3W</basicUdiDi>
    <tradeName>CellVision, 100 micron, Bürker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Attain Technologies B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000020626</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV 1100-B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:39:15.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720726199414</udiDi>
    <basicUdiDi>8720726199CellVision3W</basicUdiDi>
    <tradeName>CellVision, 100 micron, Bürker-Türk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Attain Technologies B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000020626</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV 1100-BT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:39:15.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720726199421</udiDi>
    <basicUdiDi>8720726199CellVision3W</basicUdiDi>
    <tradeName>CellVision, 100 micron, Thoma</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Attain Technologies B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000020626</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV 1100-T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:39:15.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720726199438</udiDi>
    <basicUdiDi>8720726199CellVision3W</basicUdiDi>
    <tradeName>CellVision, 200 micron, Fuchs Rosenthal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Attain Technologies B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000020626</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV 1200-FR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:39:15.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874740931</udiDi>
    <basicUdiDi>471987474QXAU6</basicUdiDi>
    <tradeName>04719874740931</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bonraybio Co., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000029512</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X QC Reticle</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:06.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874740948</udiDi>
    <basicUdiDi>471987474QXAU6</basicUdiDi>
    <tradeName>04719874740948</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bonraybio Co., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000029512</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X QC Reticle</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:06.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874741051</udiDi>
    <basicUdiDi>471987474QXBU8</basicUdiDi>
    <tradeName>04719874741051</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bonraybio Co., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000029512</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X QC Video</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:06.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874741068</udiDi>
    <basicUdiDi>471987474QXBU8</basicUdiDi>
    <tradeName>04719874741068</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bonraybio Co., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000029512</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X QC Video</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:06.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812990</udiDi>
    <basicUdiDi>B-00850004812990</basicUdiDi>
    <tradeName>SERIES IX, CUTOFF 3X, 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>19499908-6pk</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:23.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812952</udiDi>
    <basicUdiDi>B-00850004812952</basicUdiDi>
    <tradeName>AU/NZ SKREEN, 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>19482200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:22.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812945</udiDi>
    <basicUdiDi>B-00850004812945</basicUdiDi>
    <tradeName>AU/NZ SKREEN, 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>19481100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:21.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812938</udiDi>
    <basicUdiDi>B-00850004812938</basicUdiDi>
    <tradeName>AU/NZ SKREEN, Cutoff +50%, 5mL</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>19480200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:20.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812921</udiDi>
    <basicUdiDi>B-00850004812921</basicUdiDi>
    <tradeName>AU/NZ SKREEN, Cutoff -50%, 5mL</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>19480100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:16.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812914</udiDi>
    <basicUdiDi>B-00850004812914</basicUdiDi>
    <tradeName>STAT-SKREEN-H, 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>19470075</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:16.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812907</udiDi>
    <basicUdiDi>B-00850004812907</basicUdiDi>
    <tradeName>STAT-SKREEN-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>19470073</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:15.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812891</udiDi>
    <basicUdiDi>B-00850004812891</basicUdiDi>
    <tradeName>STAT-SKREEN-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>19470072</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:14.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004812884</udiDi>
    <basicUdiDi>B-00850004812884</basicUdiDi>
    <tradeName>STAT-SKREEN-H, 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>19470071</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:54:10.579Z</lastUpdated>
  </row>
</eudamedExport>