<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598800304</udiDi>
    <basicUdiDi>B-04050598800304</basicUdiDi>
    <tradeName>ID-Vit® Niacin</tradeName>
    <deviceName>ID-Vit® Niacin</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070299</emdnCode>
    <emdnDescription>VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIF003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598800403</udiDi>
    <basicUdiDi>B-04050598800403</basicUdiDi>
    <tradeName>ID-Vit® Pantothenic acid</tradeName>
    <deviceName>ID-Vit® Pantothenic acid</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070299</emdnCode>
    <emdnDescription>VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIF004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598800502</udiDi>
    <basicUdiDi>B-04050598800502</basicUdiDi>
    <tradeName>ID-Vit® Folic acid</tradeName>
    <deviceName>ID-Vit® Folic acid</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIF005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598800601</udiDi>
    <basicUdiDi>B-04050598800601</basicUdiDi>
    <tradeName>ID-Vit® Vitamin B6</tradeName>
    <deviceName>ID-Vit® Vitamin B6</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070203</emdnCode>
    <emdnDescription>VITAMIN B6</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIF006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598800700</udiDi>
    <basicUdiDi>B-04050598800700</basicUdiDi>
    <tradeName>ID-Vit® Biotin</tradeName>
    <deviceName>ID-Vit® Biotin</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070299</emdnCode>
    <emdnDescription>VITAMIN TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIF007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598801202</udiDi>
    <basicUdiDi>B-04050598801202</basicUdiDi>
    <tradeName>ID-Vit® Vitamin B12</tradeName>
    <deviceName>ID-Vit® Vitamin B12</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIF012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514601578</udiDi>
    <basicUdiDi>59075146I20-C0009_10P6</basicUdiDi>
    <tradeName>AURYX 90 Measuring Cell Maintenance Buffer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I20-C0009</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:22:24.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514601554</udiDi>
    <basicUdiDi>59075146I20-C0003_6BB</basicUdiDi>
    <tradeName>AURYX 90 Concentrated Washing Buffer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I20-C0003</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:22:22.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514601530</udiDi>
    <basicUdiDi>59075146I20-C0002_5B4</basicUdiDi>
    <tradeName>AURYX 90 Buffer</tradeName>
    <deviceName>AURYX 90 Buffer</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>I20-C0002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:22:21.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514601516</udiDi>
    <basicUdiDi>59075146I20-C0001_4AV</basicUdiDi>
    <tradeName>AURYX 90 Auffer</tradeName>
    <deviceName>AURYX 90 Auffer</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>I20-C0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:22:17.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>05744003280070</udiDi>
    <basicUdiDi>574400328CALIB46</basicUdiDi>
    <tradeName>Calibration plate</tradeName>
    <deviceName>Calibration plate</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA216</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:19.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700573004577</udiDi>
    <basicUdiDi>570057R0301P3007C008701NK</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human CD10, Clone DAK-CD10, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human CD10, Clone DAK-CD10, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA786</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:57:04.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700573004560</udiDi>
    <basicUdiDi>570057R0301P3007C015701N9</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human CD246 ALK Protein, Clone OTI1A4, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human CD246 ALK Protein, Clone OTI1A4, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA785</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:57:03.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700573004553</udiDi>
    <basicUdiDi>570057R0301P3007C008601NE</basicUdiDi>
    <tradeName>FLEX Monoclonal Rabbit Anti-Human p40, Clone DAK-p40, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Rabbit Anti-Human p40, Clone DAK-p40, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA784</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:08.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700573004546</udiDi>
    <basicUdiDi>570057R0301P3007C008501N9</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030124</emdnCode>
    <emdnDescription>CANCER ANTIGEN P16</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA783</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:07.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700573004508</udiDi>
    <basicUdiDi>570057R0301P3007C057901QD</basicUdiDi>
    <tradeName>FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51 Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51 Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA087</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:06.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700573004492</udiDi>
    <basicUdiDi>570057R0301P3007C057801Q8</basicUdiDi>
    <tradeName>FLEX Monoclonal Rabbit Anti-Human MSH6, Clone EP49 Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Rabbit Anti-Human MSH6, Clone EP49 Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA086</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:05.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700573004485</udiDi>
    <basicUdiDi>570057R0301P3007C057701Q3</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11 Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11 Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA085</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:01.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700573003730</udiDi>
    <basicUdiDi>570057R0301P3007C057601PW</basicUdiDi>
    <tradeName>FLEX Monoclonal Mouse Anti-Human MLH1, Clone ES05 Ready-to-Use (Dako Omnis)</tradeName>
    <deviceName>FLEX Monoclonal Mouse Anti-Human MLH1, Clone ES05 Ready-to-Use</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA079</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:01.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700573001736</udiDi>
    <basicUdiDi>570057P3007P3010A054501P6</basicUdiDi>
    <tradeName>PD-L1 Control Slides</tradeName>
    <deviceName>PD-L1 Control Slides</deviceName>
    <manufacturerName>Agilent Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009385</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1391</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:53:59.506Z</lastUpdated>
  </row>
</eudamedExport>