<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06438147387700</udiDi>
    <basicUdiDi>6438147EonisQ_4J</basicUdiDi>
    <tradeName>Eonis Q96</tradeName>
    <deviceName>Eonis Q96</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2044-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:19.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147376209</udiDi>
    <basicUdiDi>6438147chemagic_PrJr3L</basicUdiDi>
    <tradeName>chemagic Prime Jr-D</tradeName>
    <deviceName>chemagic Prime Jr-D</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2029-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:15.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147369324</udiDi>
    <basicUdiDi>6438147Vanadis_ViewVE</basicUdiDi>
    <tradeName>Vanadis View</tradeName>
    <deviceName>Vanadis View</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2028-0020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:10.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147369317</udiDi>
    <basicUdiDi>6438147Vanadis_CoreSA</basicUdiDi>
    <tradeName>Vanadis Core</tradeName>
    <deviceName>Vanadis Core</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2027-0020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:09.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147369300</udiDi>
    <basicUdiDi>6438147Vanadis_Extract9Y</basicUdiDi>
    <tradeName>Vanadis Extract</tradeName>
    <deviceName>Vanadis Extract</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2026-0020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:08.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147356706</udiDi>
    <basicUdiDi>6438147chemagic_360-DZ2</basicUdiDi>
    <tradeName>chemagic 360-D</tradeName>
    <deviceName>chemagic 360-D</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2024-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:04.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147332205</udiDi>
    <basicUdiDi>6438147chemagic_Prep5J</basicUdiDi>
    <tradeName>chemagic Prepito-D</tradeName>
    <deviceName>chemagic Prepito-D</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2022-0020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:00.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430041760030</udiDi>
    <basicUdiDi>643004176B0039MJ</basicUdiDi>
    <tradeName>Novodiag Instrument</tradeName>
    <deviceName>Novodiag System</deviceName>
    <manufacturerName>Mobidiag Ltd.</manufacturerName>
    <manufacturerSrn>FI-MF-000001215</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>NVD-INST-B</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:54:15.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802605639</udiDi>
    <basicUdiDi>69268026GeneXE600000001P2</basicUdiDi>
    <tradeName>AutoMated Nucleic Acid Extraction System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneX E6s</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:34:09.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713915000533</udiDi>
    <basicUdiDi>5713915BP001NK</basicUdiDi>
    <tradeName>BasePurifier</tradeName>
    <deviceName>BasePurifier™ 32 Nucleic Acid Extraction System 32 Oscillating Rods</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>715</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:31.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713915000557</udiDi>
    <basicUdiDi>5713915BT004PM</basicUdiDi>
    <tradeName>BaseTyper</tradeName>
    <deviceName>BaseTyper™ 96.4 Flexible Real-Time PCR System</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>759</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:29.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713915000540</udiDi>
    <basicUdiDi>5713915BT003PK</basicUdiDi>
    <tradeName>BaseTyper</tradeName>
    <deviceName>BaseTyper™ 96.6 Flexible Real-Time PCR System</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>758</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:28.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713915000526</udiDi>
    <basicUdiDi>5713915BP002NM</basicUdiDi>
    <tradeName>BasePurifier</tradeName>
    <deviceName>BasePurifier™ 96 Nucleic Acid Extraction System 96 Rotating Rods</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>719</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:15.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713915000519</udiDi>
    <basicUdiDi>5713915BP003NP</basicUdiDi>
    <tradeName>BasePurifier</tradeName>
    <deviceName>BasePurifier™ 48 Large Volume Nucleic Acid Extraction System 48 Rotating Rods</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>718</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:14.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713915000144</udiDi>
    <basicUdiDi>5713915BT002PH</basicUdiDi>
    <tradeName>BaseTyper</tradeName>
    <deviceName>BaseTyper™ 16.2 Portable Real-Time PCR System</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>712</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:09.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>05713915000014</udiDi>
    <basicUdiDi>5713915BT001PF</basicUdiDi>
    <tradeName>BaseTyper</tradeName>
    <deviceName>BaseTyper™ 48.4 Quiet HRM Real-Time PCR System</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>754</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:08.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860172</udiDi>
    <basicUdiDi>506065486GS-00X2F</basicUdiDi>
    <tradeName>Genedrive® System</tradeName>
    <deviceName>Genedrive® System</deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-002 V4.0</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:30:02.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060536830231</udiDi>
    <basicUdiDi>506053683FQA001Y4</basicUdiDi>
    <tradeName>DNA Fragmentation Quantification Assay</tradeName>
    <deviceName>DNA Fragmentation Quantification Assay</deviceName>
    <manufacturerName>EntroGen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022721</manufacturerSrn>
    <authorisedRepresentativeName>TANJA TOPOVSEK S.P.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022518</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FQA-RT40</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:23:05.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056793800001</udiDi>
    <basicUdiDi>50567938OND-GRD-Dx1-RGLKR</basicUdiDi>
    <tradeName>GridION Sequencing Device Dx1 RGL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxford Nanopore Diagnostics Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000046755</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OND-GRD-DX1-RGL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:01:28.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152709485</udiDi>
    <basicUdiDi>50561527LYO5NQ</basicUdiDi>
    <tradeName>MAST ISOPLEX® CRE-ART</tradeName>
    <deviceName>MAST ISOPLEX® CRE-ART</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050285</emdnCode>
    <emdnDescription>MICRO-ARRAY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNA/LYO5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:09.937Z</lastUpdated>
  </row>
</eudamedExport>