<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>15065026245158</udiDi>
    <basicUdiDi>B-15065026245158</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>General Chemistry III 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>TA10004</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:22.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245141</udiDi>
    <basicUdiDi>B-15065026245141</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>General Chemistry II 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>TA10003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:21.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245134</udiDi>
    <basicUdiDi>B-15065026245134</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>General Chemistry I 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>TA10002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:17.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763969</udiDi>
    <basicUdiDi>B-15065023763969</basicUdiDi>
    <tradeName>TruLyta</tradeName>
    <deviceName>Electrolyte Test Cartridge</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TL10002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:36:47.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109214MQ</udiDi>
    <basicUdiDi>B-109214MQ</basicUdiDi>
    <tradeName>SPOTCHEM D Panel-E</tradeName>
    <deviceName>SPOTCHEM D Panel-E</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>109214</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:06.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109213MN</udiDi>
    <basicUdiDi>B-109213MN</basicUdiDi>
    <tradeName>SPOTCHEM D Panel-D</tradeName>
    <deviceName>SPOTCHEM D Panel-D</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>109213</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:03.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109212ML</udiDi>
    <basicUdiDi>B-109212ML</basicUdiDi>
    <tradeName>SPOTCHEM D Panel-C</tradeName>
    <deviceName>SPOTCHEM D Panel-C</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>109212</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:01.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105107LS</udiDi>
    <basicUdiDi>B-105107LS</basicUdiDi>
    <tradeName>SPOTCHEM D Screening</tradeName>
    <deviceName>SPOTCHEM D Screening</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>105107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:15.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105105LN</udiDi>
    <basicUdiDi>B-105105LN</basicUdiDi>
    <tradeName>SPOTCHEM D Liver-D</tradeName>
    <deviceName>SPOTCHEM D Liver-D</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>105105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:11.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102734M6</udiDi>
    <basicUdiDi>B-102734M6</basicUdiDi>
    <tradeName>SPOTCHEM D Panel-V2</tradeName>
    <deviceName>SPOTCHEM D Panel-V2</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>102734</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:59.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102733M4</udiDi>
    <basicUdiDi>B-102733M4</basicUdiDi>
    <tradeName>SPOTCHEM D Total-A2</tradeName>
    <deviceName>SPOTCHEM D Total-A2</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>102733</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:59.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102732M2</udiDi>
    <basicUdiDi>B-102732M2</basicUdiDi>
    <tradeName>SPOTCHEM D Stat2</tradeName>
    <deviceName>SPOTCHEM D Stat2</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>102732</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:57.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102731LY</udiDi>
    <basicUdiDi>B-102731LY</basicUdiDi>
    <tradeName>SPOTCHEM D Metabolic2</tradeName>
    <deviceName>SPOTCHEM D Metabolic2</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>102731</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:55.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102728MB</udiDi>
    <basicUdiDi>B-102728MB</basicUdiDi>
    <tradeName>SPOTCHEM II PANEL-V2</tradeName>
    <deviceName>SPOTCHEM II PANEL-V2</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>102728</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:53.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102730LW</udiDi>
    <basicUdiDi>B-102730LW</basicUdiDi>
    <tradeName>SPOTCHEM D Kidney2</tradeName>
    <deviceName>SPOTCHEM D Kidney2</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>102730</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:52.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102727M9</udiDi>
    <basicUdiDi>B-102727M9</basicUdiDi>
    <tradeName>SPOTCHEM II Kidney-3</tradeName>
    <deviceName>SPOTCHEM II Kidney-3</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>102727</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:46.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102725M5</udiDi>
    <basicUdiDi>B-102725M5</basicUdiDi>
    <tradeName>SPOTCHEM II PANEL-V2</tradeName>
    <deviceName>SPOTCHEM II PANEL-V2</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>102725</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:32.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102724M3</udiDi>
    <basicUdiDi>B-102724M3</basicUdiDi>
    <tradeName>SPOTCHEM II Kidney-3</tradeName>
    <deviceName>SPOTCHEM II Kidney-3</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>102724</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:31.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-10000DR</udiDi>
    <basicUdiDi>B-10000DR</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep®  Complete Kit for Aromatic Amino Acids in Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:34:22.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057441870046</udiDi>
    <basicUdiDi>B-08057441870046</basicUdiDi>
    <tradeName>ROUTINE KIT ANTIBIOTICI SET B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CoQua Lab s.r.l</manufacturerName>
    <manufacturerSrn>IT-MF-000053829</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATB100B_KIT250</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:33:04.483Z</lastUpdated>
  </row>
</eudamedExport>