<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>D-14405FK</udiDi>
    <basicUdiDi>B-14405FK</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>14405</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:08:00.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-108203MC</udiDi>
    <basicUdiDi>B-108203MC</basicUdiDi>
    <tradeName>AutionIDaten (AE-4070)</tradeName>
    <deviceName>AutionIDaten (AE-4070)</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>108203</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:38:14.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-106026LY</udiDi>
    <basicUdiDi>B-106026LY</basicUdiDi>
    <tradeName>AUTION EYE (AI-4510)</tradeName>
    <deviceName>AUTION EYE (AI-4510)</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>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106026</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:28:13.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105885NH</udiDi>
    <basicUdiDi>B-105885NH</basicUdiDi>
    <tradeName>AUTION MAX (AX-4060)</tradeName>
    <deviceName>AUTION MAX (AX-4060)</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>105885</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:28:09.467Z</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>D-102678MM</udiDi>
    <basicUdiDi>B-102678MM</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>102678</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:26.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102677MK</udiDi>
    <basicUdiDi>B-102677MK</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>102677</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:24.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102676MH</udiDi>
    <basicUdiDi>B-102676MH</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>102676</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:22.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102674MD</udiDi>
    <basicUdiDi>B-102674MD</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>102674</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:20.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100528LK</udiDi>
    <basicUdiDi>B-100528LK</basicUdiDi>
    <tradeName>AUTION MAX (AX-4060)</tradeName>
    <deviceName>AUTION MAX (AX-4060)</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>100528</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:36:33.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100525LD</udiDi>
    <basicUdiDi>B-100525LD</basicUdiDi>
    <tradeName>AUTION MAX (AX-4060)</tradeName>
    <deviceName>AUTION MAX (AX-4060)</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>100525</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:36:29.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134664017</udiDi>
    <basicUdiDi>B-08806134664017</basicUdiDi>
    <tradeName>08806134664017</tradeName>
    <deviceName>GCare Lipid</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCM110M10</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:48.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065158201</udiDi>
    <basicUdiDi>B-08800065158201</basicUdiDi>
    <tradeName>CERA-CHEK™ Lactate Measuring System</tradeName>
    <deviceName>Lactate Measuring System</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L400M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:13.644Z</lastUpdated>
  </row>
</eudamedExport>