<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-MOBPLUR-AVJ</udiDi>
    <basicUdiDi>B-MOBPLUR-AVJ</basicUdiDi>
    <tradeName>URA - CLINICAL CHEMISTRY ANALYZER</tradeName>
    <deviceName>Clinical Chemistry Analyzer</deviceName>
    <manufacturerName>Medsource Ozone Biomedicals Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000042128</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>UR-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:08:56.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOBPLEC9005PD</udiDi>
    <basicUdiDi>B-MOBPLEC9005PD</basicUdiDi>
    <tradeName>URA PREMIO - CLINICAL CHEMISTRY ANALYZER</tradeName>
    <deviceName>Clinical Chemistry Analyzer</deviceName>
    <manufacturerName>Medsource Ozone Biomedicals Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000042128</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EC9005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:08:55.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HYDRA09PLUSTD</udiDi>
    <basicUdiDi>B-HYDRA09PLUSTD</basicUdiDi>
    <tradeName>D-HYDRA09PLUSTD</tradeName>
    <deviceName>Hydra 09 Plus</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NHY09</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:44.472Z</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-BN344411X6</udiDi>
    <basicUdiDi>B-BN344411X6</basicUdiDi>
    <tradeName>UF-5000</tradeName>
    <deviceName>Fully Automated Urine Particle Analyzer UF-5000</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BN344411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:28:19.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BH756473X3</udiDi>
    <basicUdiDi>B-BH756473X3</basicUdiDi>
    <tradeName>UC-3500</tradeName>
    <deviceName>Fully Automated Urine Particle Analyzer UC-3500</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BH756473</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:13.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BA212287P4</udiDi>
    <basicUdiDi>B-BA212287P4</basicUdiDi>
    <tradeName>UF-4000</tradeName>
    <deviceName>Fully Automated Urine Particle Analyzer UF-4000</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA212287</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:23:09.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-79053JF</udiDi>
    <basicUdiDi>B-79053JF</basicUdiDi>
    <tradeName>Concentrated Washing Solution 3</tradeName>
    <deviceName>Concentrated Washing Solution 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>W020101020185</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79053</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:02.939Z</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-20707FM</udiDi>
    <basicUdiDi>B-20707FM</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName>PocketChem UA (PU-4010)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20707</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:38:13.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20705FH</udiDi>
    <basicUdiDi>B-20705FH</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName>PocketChem UA (PU-4010)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20705</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:38:12.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20704FF</udiDi>
    <basicUdiDi>B-20704FF</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName>PocketChem UA (PU-4010)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20704</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:18.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20504F5</udiDi>
    <basicUdiDi>B-20504F5</basicUdiDi>
    <tradeName>PocketChem BA (PA-4140)</tradeName>
    <deviceName>PocketChem BA (PA-4140)</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>W0201010203</emdnCode>
    <emdnDescription>BLOOD-AMMONIA CHECKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20504</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:13.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20503F3</udiDi>
    <basicUdiDi>B-20503F3</basicUdiDi>
    <tradeName>PocketChem BA (PA-4140)</tradeName>
    <deviceName>PocketChem BA (PA-4140)</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>W0201010203</emdnCode>
    <emdnDescription>BLOOD-AMMONIA CHECKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20503</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:13.073Z</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-14506FS</udiDi>
    <basicUdiDi>B-14506FS</basicUdiDi>
    <tradeName>AUTION MAX (AX-4030)</tradeName>
    <deviceName>AUTION MAX (AX-4030)</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14506</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:08:12.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14504FN</udiDi>
    <basicUdiDi>B-14504FN</basicUdiDi>
    <tradeName>AUTION MAX (AX-4030)</tradeName>
    <deviceName>AUTION MAX (AX-4030)</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>14504</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:08:12.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14440FM</udiDi>
    <basicUdiDi>B-14440FM</basicUdiDi>
    <tradeName>AUTION ELEVEN (AE-4020)</tradeName>
    <deviceName>AUTION ELEVEN (AE-4020)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14440</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:08:02.490Z</lastUpdated>
  </row>
</eudamedExport>