<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-77418JK</udiDi>
    <basicUdiDi>B-77418JK</basicUdiDi>
    <tradeName>SPOTCHEM II STAT-1</tradeName>
    <deviceName>SPOTCHEM II STAT-1</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77418</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:32.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77417JH</udiDi>
    <basicUdiDi>B-77417JH</basicUdiDi>
    <tradeName>SPOTCHEM II Liver-1</tradeName>
    <deviceName>SPOTCHEM II Liver-1</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77417</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:32.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77189JT</udiDi>
    <basicUdiDi>B-77189JT</basicUdiDi>
    <tradeName>SPOTCHEM II PANEL-V</tradeName>
    <deviceName>SPOTCHEM II PANEL-V</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77189</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:20:22.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77188JR</udiDi>
    <basicUdiDi>B-77188JR</basicUdiDi>
    <tradeName>SPOTCHEM II KENSHIN-2</tradeName>
    <deviceName>SPOTCHEM II KENSHIN-2</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77188</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:20:21.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77185JK</udiDi>
    <basicUdiDi>B-77185JK</basicUdiDi>
    <tradeName>SPOTCHEM II PANEL-2</tradeName>
    <deviceName>SPOTCHEM II PANEL-2</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77185</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:20:17.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77187JP</udiDi>
    <basicUdiDi>B-77187JP</basicUdiDi>
    <tradeName>SPOTCHEM II Kidney-2</tradeName>
    <deviceName>SPOTCHEM II Kidney-2</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77187</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:20:16.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77186JM</udiDi>
    <basicUdiDi>B-77186JM</basicUdiDi>
    <tradeName>SPOTCHEM II Heart-2</tradeName>
    <deviceName>SPOTCHEM II Heart-2</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77186</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:20:16.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77184JH</udiDi>
    <basicUdiDi>B-77184JH</basicUdiDi>
    <tradeName>SPOTCHEM II PANEL-1</tradeName>
    <deviceName>SPOTCHEM II PANEL-1</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77184</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:20:15.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77183JF</udiDi>
    <basicUdiDi>B-77183JF</basicUdiDi>
    <tradeName>SPOTCHEM II STAT-1</tradeName>
    <deviceName>SPOTCHEM II STAT-1</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77183</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:59.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77182JD</udiDi>
    <basicUdiDi>B-77182JD</basicUdiDi>
    <tradeName>SPOTCHEM II Liver-1</tradeName>
    <deviceName>SPOTCHEM II Liver-1</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77182</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:58.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-469110QL</udiDi>
    <basicUdiDi>B-469110QL</basicUdiDi>
    <tradeName>SYNCHRON Systems NO FOAM</tradeName>
    <deviceName>SYNCHRON Systems NO FOAM</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469110</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:13.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467826RQ</udiDi>
    <basicUdiDi>B-467826RQ</basicUdiDi>
    <tradeName>Sample Diluent 1 DIL1</tradeName>
    <deviceName>Sample Diluent 1 DIL1</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467826</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:11.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-445967R7</udiDi>
    <basicUdiDi>B-445967R7</basicUdiDi>
    <tradeName>SYNCHRON Systems Antifoam</tradeName>
    <deviceName>SYNCHRON Systems Antifoam</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445967</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:53.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-445865QW</udiDi>
    <basicUdiDi>B-445865QW</basicUdiDi>
    <tradeName>SYNCHRON Systems Wash Concentrate II</tradeName>
    <deviceName>SYNCHRON Systems Wash Concentrate II</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445865</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:37.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245219</udiDi>
    <basicUdiDi>B-15065026245219</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>Myocardial Enzyme Test Panel</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA10010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:30.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245202</udiDi>
    <basicUdiDi>B-15065026245202</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>Glucose and Lipid Test Panel</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA10009</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:29.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245196</udiDi>
    <basicUdiDi>B-15065026245196</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>Emergency Test Panel</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA10008</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:28.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245189</udiDi>
    <basicUdiDi>B-15065026245189</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>Liver Function Test Panel</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA10007</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:27.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245172</udiDi>
    <basicUdiDi>B-15065026245172</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>Renal Function Test Panel</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA10006</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:23.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245165</udiDi>
    <basicUdiDi>B-15065026245165</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>Electrolyte Test Panel</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA10005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:22.839Z</lastUpdated>
  </row>
</eudamedExport>