<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>14987481165066</udiDi>
    <basicUdiDi>498748114987481165066ZB</basicUdiDi>
    <tradeName>L-Type LDL-C Reagent 1</tradeName>
    <deviceName>L-Type LDL-C Reagent 1, L-Type LDL-C Reagent  2, LDL-C Calibrator</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>994-24991</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:15.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481165011</udiDi>
    <basicUdiDi>498748114987481165028Z3</basicUdiDi>
    <tradeName>HDL-C Calibrator</tradeName>
    <deviceName>L-Type HDL-C Reagent 1, L-Type HDL-C Reagent  2, HDL-C Calibrator</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993-73291</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:12.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481164939</udiDi>
    <basicUdiDi>4987481149874811649392H</basicUdiDi>
    <tradeName>Bilirubin Calibrator</tradeName>
    <deviceName>Bilirubin Calibrator</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>994-24491</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:11.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481164915</udiDi>
    <basicUdiDi>49874811498748116491523</basicUdiDi>
    <tradeName>L-Type Total Bilirubin  Reagent 1</tradeName>
    <deviceName>L-Type Total Bilirubin  Reagent 1, L-Type Total Bilirubin Reagent  2</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>992-24291</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:10.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481164892</udiDi>
    <basicUdiDi>4987481149874811648922G</basicUdiDi>
    <tradeName>L-Type Direct Bilirubin  Reagent 1</tradeName>
    <deviceName>L-Type Direct Bilirubin  Reagent 1, L-Type Direct Bilirubin Reagent  2</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>990-24091</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:08.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481164823</udiDi>
    <basicUdiDi>498748114987481164823ZS</basicUdiDi>
    <tradeName>Ketone Body Calibrator 300</tradeName>
    <deviceName>Ketone Body Calibrator 300</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993-73791</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:06.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481164465</udiDi>
    <basicUdiDi>498748114987481164465ZN</basicUdiDi>
    <tradeName>μTASWako AFP-L3 Sample Dilution Buffer</tradeName>
    <deviceName>μTASWako AFP-L3 Sample Dilution Buffer</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997-61501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:04.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481164427</udiDi>
    <basicUdiDi>498748114987481164427ZE</basicUdiDi>
    <tradeName>μTASWako Chip Cassette</tradeName>
    <deviceName>μTASWako Chip Cassette</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993-61601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:04.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481164502</udiDi>
    <basicUdiDi>498748114987481164502Z3</basicUdiDi>
    <tradeName>μTASWako Wash Solution</tradeName>
    <deviceName>μTASWako Wash Solution</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>991-60801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:02.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481163864</udiDi>
    <basicUdiDi>49874811498748116386424</basicUdiDi>
    <tradeName>BC Tip EXT</tradeName>
    <deviceName>BC Tip EXT, BC Tip 1000-R</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503020202</emdnCode>
    <emdnDescription>PIPETTES, TIPS WITHOUT FILTER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>995-05001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:00.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481163857</udiDi>
    <basicUdiDi>49874811498748116385727</basicUdiDi>
    <tradeName>Aluminum Cap</tradeName>
    <deviceName>Aluminum Cap</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>995-04901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:06:43.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481163819</udiDi>
    <basicUdiDi>498748114987481163819ZU</basicUdiDi>
    <tradeName>β-Glucan Sample Diluent</tradeName>
    <deviceName>β-Glucan Sample Diluent</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-04301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:06:43.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987481164802</udiDi>
    <basicUdiDi>49874814987481164802UR</basicUdiDi>
    <tradeName>Autokit Total Ketone Bodies R1 Set</tradeName>
    <deviceName>Autokit Total Ketone Bodies R1 Set, Autokit Total Ketone Bodies R2 Set</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>996-73301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:15.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987481165120</udiDi>
    <basicUdiDi>49874814987481165120TX</basicUdiDi>
    <tradeName>NEFA-HR(2) R1 Set</tradeName>
    <deviceName>NEFA-HR(2) R1 Set, NEFA-HR(2) R2 Set, NEFA Standard</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NON ESTERIFIED FATTY ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>994-91801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:14.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987481164970</udiDi>
    <basicUdiDi>49874814987481164970VF</basicUdiDi>
    <tradeName>Hyaluronic acid-LT Set</tradeName>
    <deviceName>Hyaluronic acid-LT Set, HA Calibrator Set, HA Control Set</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HYALURONIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-81101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:14.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987481164833</udiDi>
    <basicUdiDi>49874814987481164833V4</basicUdiDi>
    <tradeName>Autokit CH50 Set</tradeName>
    <deviceName>Autokit CH50 Set, CH50 Calibrator Set, Complement Control Set</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TOTAL COMPLEMENT ACTIVITY (CH50)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>993-40601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:13.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987481164789</udiDi>
    <basicUdiDi>49874814987481164789VS</basicUdiDi>
    <tradeName>Autokit 3-HB R1 Set</tradeName>
    <deviceName>Autokit 3-HB R1 Set, Autokit 3-HB R2 Set</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>998-73501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:11.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987481164413</udiDi>
    <basicUdiDi>49874814987481164413UA</basicUdiDi>
    <tradeName>μTASWako DCP</tradeName>
    <deviceName>μTASWako DCP, μTASWako DCP Calibrator Set, μTASWako DCP Control L, μTASWako DCP Control H</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>995-60701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:10.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987481164390</udiDi>
    <basicUdiDi>49874814987481164390UP</basicUdiDi>
    <tradeName>μTASWako AFP-L3</tradeName>
    <deviceName>μTASWako AFP-L3, μTASWako AFP-L3 Calibrator Set, μTASWako AFP-L3 Control L, μTASWako AFP-L3 Control H</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-60601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:10.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987481163829</udiDi>
    <basicUdiDi>498748114987481163802ZB</basicUdiDi>
    <tradeName>LAL Control</tradeName>
    <deviceName>β-Glucan Test R1: Pretreatment Solution, β-Glucan Test R2: LAL Reagent, LAL Control</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYCOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>995-04401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:03:09.391Z</lastUpdated>
  </row>
</eudamedExport>