<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>EABA11000000E1</udiDi>
    <basicUdiDi>++EABA11000000E7F</basicUdiDi>
    <tradeName>Piccolo Xpress</tradeName>
    <deviceName>Piccolo Xpress chemistry analyzer</deviceName>
    <manufacturerName>Abaxis, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021651</manufacturerSrn>
    <authorisedRepresentativeName>ABAXIS Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000017984</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100-0000E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:55:13.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EABA11000000ER1</udiDi>
    <basicUdiDi>++EABA11000000ER5X</basicUdiDi>
    <tradeName>Piccolo Xpress</tradeName>
    <deviceName>Piccolo Xpress chemistry analyzer, recertified</deviceName>
    <manufacturerName>Abaxis, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021651</manufacturerSrn>
    <authorisedRepresentativeName>ABAXIS Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000017984</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100-0000ER</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:46:21.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PartnumberA097916X</udiDi>
    <basicUdiDi>B-PartnumberA097916X</basicUdiDi>
    <tradeName>IMMAGE UDR Kit (1-pack)</tradeName>
    <deviceName>IMMAGE UDR Kit (1-pack)</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>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A09791</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:22:19.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ChemistryAnalyzerHC</udiDi>
    <basicUdiDi>B-ChemistryAnalyzerHC</basicUdiDi>
    <tradeName>NS BIOTEC Chemistry Analyzer</tradeName>
    <deviceName>NS BIOTEC Chemistry Analyzer</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SCA 1000/1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:15.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-443729Q7</udiDi>
    <basicUdiDi>B-443729Q7</basicUdiDi>
    <tradeName>SYNCHRON UDR Kit (2-pack)</tradeName>
    <deviceName>SYNCHRON UDR Kit (2-pack)</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>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>443729</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:21.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-18306GC</udiDi>
    <basicUdiDi>B-18306GC</basicUdiDi>
    <tradeName>SPOTCHEM EZ (SP-4430)</tradeName>
    <deviceName>SPOTCHEM EZ (SP-4430)</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>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18306</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:28:11.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-18304G8</udiDi>
    <basicUdiDi>B-18304G8</basicUdiDi>
    <tradeName>SPOTCHEM EZ (SP-4430)</tradeName>
    <deviceName>SPOTCHEM EZ (SP-4430)</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>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18304</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:28:10.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105581MS</udiDi>
    <basicUdiDi>B-105581MS</basicUdiDi>
    <tradeName>The Lab 004 (DB-3910)</tradeName>
    <deviceName>The Lab 004 (DB-3910)</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>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105581</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:30.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156145534</udiDi>
    <basicUdiDi>8592156CCIN0053SL</basicUdiDi>
    <tradeName>XL-1000 without ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010107</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:50.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156143202</udiDi>
    <basicUdiDi>8592156CCIN0052SJ</basicUdiDi>
    <tradeName>XL-640 without ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:50.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156143851</udiDi>
    <basicUdiDi>8592156CCIN0051SG</basicUdiDi>
    <tradeName>XL-200 without ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:50.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156143165</udiDi>
    <basicUdiDi>8592156CCIN0050SE</basicUdiDi>
    <tradeName>XL -180 without ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00038</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:50.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700860419</udiDi>
    <basicUdiDi>37017008ProS-SeriesW6</basicUdiDi>
    <tradeName>Selectra ProS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700864783</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700864790</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700864806</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-406</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700864813</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-407</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700864820</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-439</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700864837</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-439P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700864905</udiDi>
    <basicUdiDi>37017008ProS-SeriesW6</basicUdiDi>
    <tradeName>Selectra ProS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003-541</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.317Z</lastUpdated>
  </row>
</eudamedExport>