<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00816879028782</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Cuvette Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX64007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816879028805</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Anti-evaporation Caps</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX64009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975879670071</udiDi>
    <basicUdiDi>697587967KLS00019Q</basicUdiDi>
    <tradeName>Automatic Chemiluminescence  Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keylights Biotechnology (Chongqing) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033853</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BioCLIA 1900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:42:43.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975879670101</udiDi>
    <basicUdiDi>697587967KLS00019Q</basicUdiDi>
    <tradeName>Automatic Chemiluminescence  Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Keylights Biotechnology (Chongqing) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033853</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BioCLIA 6900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:42:41.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157633247</udiDi>
    <basicUdiDi>426015763899BKCSol3-4XXFT</basicUdiDi>
    <tradeName>B·R·A·H·M·S KRYPTOR compact SOLUTION 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89984</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T15:04:38.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157638655</udiDi>
    <basicUdiDi>426015763899BSol3-4KGXXLM</basicUdiDi>
    <tradeName>B·R·A·H·M·S Solution 3 KRYPTOR GOLD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89993</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T15:04:38.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147335022</udiDi>
    <basicUdiDi>6438147AutoDELFIA_PPP2</basicUdiDi>
    <tradeName>AutoDELFIA Automatic Immunoassay System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1235-5220</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:36:20.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115001713</udiDi>
    <basicUdiDi>6438115QRgoPlusDR</basicUdiDi>
    <tradeName>QuikRead go Plus Instrument</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020205</emdnCode>
    <emdnDescription>TURBIDIMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>155377</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:14.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115001706</udiDi>
    <basicUdiDi>6438115QRgoPlusDR</basicUdiDi>
    <tradeName>QuikRead go Plus Instrument</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020205</emdnCode>
    <emdnDescription>TURBIDIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155375</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:13.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115001690</udiDi>
    <basicUdiDi>6438115QRgoPlusDR</basicUdiDi>
    <tradeName>QuikRead go Plus Instrument</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020205</emdnCode>
    <emdnDescription>TURBIDIMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>155376</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:12.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115001263</udiDi>
    <basicUdiDi>6438115QRgoInstrumentF8</basicUdiDi>
    <tradeName>QuikRead go Instrument</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020205</emdnCode>
    <emdnDescription>TURBIDIMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>149915</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:07:48.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115000181</udiDi>
    <basicUdiDi>6438115QRgoInstrumentF8</basicUdiDi>
    <tradeName>QuikRead go Instrument</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020205</emdnCode>
    <emdnDescription>TURBIDIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135867</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:49.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115000174</udiDi>
    <basicUdiDi>6438115QRgoInstrumentF8</basicUdiDi>
    <tradeName>QuikRead go Instrument</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020205</emdnCode>
    <emdnDescription>TURBIDIMETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>136196</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:48.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026355214</udiDi>
    <basicUdiDi>4987026TD-OCEQZ5</basicUdiDi>
    <tradeName>OC-SENSOR Ceres</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MV5K00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562022151</udiDi>
    <basicUdiDi>4987562STROMATOLYSER3WPE8</basicUdiDi>
    <tradeName>STROMATOLYSER-3WP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>874-0331-9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:38.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003280056</udiDi>
    <basicUdiDi>574400328SOFTWE5</basicUdiDi>
    <tradeName>Release 13AUG2012</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020282</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v12-0612</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003280063</udiDi>
    <basicUdiDi>574400328SOFTWE5</basicUdiDi>
    <tradeName>Release 23SEP2013</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020282</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v13-0913</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003280100</udiDi>
    <basicUdiDi>574400328RINSECH</basicUdiDi>
    <tradeName>Acidic clean for Histareader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA709</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003280131</udiDi>
    <basicUdiDi>574400328PIPESBP</basicUdiDi>
    <tradeName>Pipes buffer 900 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA706.900</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003280148</udiDi>
    <basicUdiDi>574400328PIPESBP</basicUdiDi>
    <tradeName>Pipes buffer 1 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA706.1000</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.747Z</lastUpdated>
  </row>
</eudamedExport>