<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-109516NB</udiDi>
    <basicUdiDi>B-109516NB</basicUdiDi>
    <tradeName>GLUCOCARD W Test Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109516</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:25.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109523N8</udiDi>
    <basicUdiDi>B-109523N8</basicUdiDi>
    <tradeName>GLUCOCARD S (GT-7110)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109523</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:18.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109574NR</udiDi>
    <basicUdiDi>B-109574NR</basicUdiDi>
    <tradeName>GLUCOCARD S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109574</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:18.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14405FK</udiDi>
    <basicUdiDi>B-14405FK</basicUdiDi>
    <tradeName>AUTION ELEVEN (AE-4020)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:13.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14440FM</udiDi>
    <basicUdiDi>B-14440FM</basicUdiDi>
    <tradeName>AUTION ELEVEN (AE-4020)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:13.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14504FN</udiDi>
    <basicUdiDi>B-14504FN</basicUdiDi>
    <tradeName>AUTION MAX (AX-4030)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>14504</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:06.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14506FS</udiDi>
    <basicUdiDi>B-14506FS</basicUdiDi>
    <tradeName>AUTION MAX (AX-4030)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14506</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:06.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-17402G2</udiDi>
    <basicUdiDi>B-17402G2</basicUdiDi>
    <tradeName>SPOTCHEM D-00 (SD-9810)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:05.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-17503G9</udiDi>
    <basicUdiDi>B-17503G9</basicUdiDi>
    <tradeName>SPOTCHEM D-01 (SD-3810)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17503</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:05.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-17603GE</udiDi>
    <basicUdiDi>B-17603GE</basicUdiDi>
    <tradeName>SPOTCHEM D-02 (SD-4810)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17603</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:04.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-17703GK</udiDi>
    <basicUdiDi>B-17703GK</basicUdiDi>
    <tradeName>SPOTCHEM D-03 (SD-4820)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17703</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:04.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-18304G8</udiDi>
    <basicUdiDi>B-18304G8</basicUdiDi>
    <tradeName>SPOTCHEM EZ (SP-4430)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:04.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-18306GC</udiDi>
    <basicUdiDi>B-18306GC</basicUdiDi>
    <tradeName>SPOTCHEM EZ (SP-4430)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18306</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:04.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20286FJ</udiDi>
    <basicUdiDi>B-20286FJ</basicUdiDi>
    <tradeName>AUTION Sticks 10EA</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20286</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:02.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20503F3</udiDi>
    <basicUdiDi>B-20503F3</basicUdiDi>
    <tradeName>PocketChem BA (PA-4140)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20503</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:02.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20504F5</udiDi>
    <basicUdiDi>B-20504F5</basicUdiDi>
    <tradeName>PocketChem BA (PA-4140)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20504</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:02.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20704FF</udiDi>
    <basicUdiDi>B-20704FF</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20704</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:02.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20705FH</udiDi>
    <basicUdiDi>B-20705FH</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20705</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:02.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20707FM</udiDi>
    <basicUdiDi>B-20707FM</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20707</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:02.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-23905GG</udiDi>
    <basicUdiDi>B-23905GG</basicUdiDi>
    <tradeName>Uriflet S 9UB</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23905</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:45:54.761Z</lastUpdated>
  </row>
</eudamedExport>