<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04260158683548</udiDi>
    <basicUdiDi>42601586PDDETECTSE</basicUdiDi>
    <tradeName>PD DETECT II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AIDA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000040784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAA-002_02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T14:55:06.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438172401082</udiDi>
    <basicUdiDi>B-06438172401082</basicUdiDi>
    <tradeName>NeoMass CAH Rinsing Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3467706</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:41:04.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438172401075</udiDi>
    <basicUdiDi>B-06438172401075</basicUdiDi>
    <tradeName>NeoMass CAH Mobile Phase B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3467705</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:41:02.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438172401068</udiDi>
    <basicUdiDi>B-06438172401068</basicUdiDi>
    <tradeName>NeoMass CAH Mobile Phase A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3467704</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:41:00.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438172401051</udiDi>
    <basicUdiDi>B-06438172401051</basicUdiDi>
    <tradeName>NeoMass CAH Reconstitution Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3467703</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:40:59.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147356829</udiDi>
    <basicUdiDi>B-06438147356829</basicUdiDi>
    <tradeName>NeoBase 2 Succinylacetone Assay Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3046-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:36:43.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147323029</udiDi>
    <basicUdiDi>B-06438147323029</basicUdiDi>
    <tradeName>MSMS Vitamin D Tool Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3076-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:36:01.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147323012</udiDi>
    <basicUdiDi>B-06438147323012</basicUdiDi>
    <tradeName>MSMS Vitamin D Derivatization Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3078-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:35:59.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147322701</udiDi>
    <basicUdiDi>B-06438147322701</basicUdiDi>
    <tradeName>MSMS Vitamin D kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3075-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:35:58.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147322015</udiDi>
    <basicUdiDi>B-06438147322015</basicUdiDi>
    <tradeName>CHS MSMS Steroids kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3070-0020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:35:56.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147316441</udiDi>
    <basicUdiDi>B-06438147316441</basicUdiDi>
    <tradeName>CHS MSMS Steroids Tool Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3071-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:35:49.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147295708</udiDi>
    <basicUdiDi>B-06438147295708</basicUdiDi>
    <tradeName>NeoBase Succinylacetone Assay Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3042-0020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:35:29.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147009473</udiDi>
    <basicUdiDi>B-06438147009473</basicUdiDi>
    <tradeName>AutoDELFIA hTSH Ultra</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B042-201</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:34:28.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147009435</udiDi>
    <basicUdiDi>B-06438147009435</basicUdiDi>
    <tradeName>AutoDELFIA hLH Spec kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B031-101</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:34:27.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147009206</udiDi>
    <basicUdiDi>B-06438147009206</basicUdiDi>
    <tradeName>DELFIA hLH Spec kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A031-101</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:34:19.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>04053228049432</udiDi>
    <basicUdiDi>4053228AUMMQCY000000001DS</basicUdiDi>
    <tradeName>QIAcuityDx Universal MasterMix Kit (5mL)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:25:08.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>03366160501243</udiDi>
    <basicUdiDi>33661605EBE0774L</basicUdiDi>
    <tradeName>EurobioPlex DermaXtract</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBE-077-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:43:10.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>03366160501250</udiDi>
    <basicUdiDi>33661605EBE0774L</basicUdiDi>
    <tradeName>EurobioPlex DermaXtract</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBE-077-200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:42:58.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000422</udiDi>
    <basicUdiDi>0627595H0800HX</basicUdiDi>
    <tradeName>PrepIT L2P</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT-L2P-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627595000552</udiDi>
    <basicUdiDi>0627595I0900JF</basicUdiDi>
    <tradeName>OMNIgene Liquefaction Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OM-LQR-1600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:19.322Z</lastUpdated>
  </row>
</eudamedExport>