<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-HU5101011L7</udiDi>
    <basicUdiDi>B-HU5101011L7</basicUdiDi>
    <tradeName>D-HU5101011L7</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5101011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:58:32.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5101010L5</udiDi>
    <basicUdiDi>B-HU5101010L5</basicUdiDi>
    <tradeName>D-HU5101010L5</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5101010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:58:31.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5101009LL</udiDi>
    <basicUdiDi>B-HU5101009LL</basicUdiDi>
    <tradeName>D-HU5101009LL</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5101009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:58:30.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5101008LJ</udiDi>
    <basicUdiDi>B-HU5101008LJ</basicUdiDi>
    <tradeName>D-HU5101008LJ</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5101008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:58:29.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5101007LG</udiDi>
    <basicUdiDi>B-HU5101007LG</basicUdiDi>
    <tradeName>D-HU5101007LG</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5101007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:58:25.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5101006LE</udiDi>
    <basicUdiDi>B-HU5101006LE</basicUdiDi>
    <tradeName>D-HU5101006LE</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5101006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:58:25.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5101005LC</udiDi>
    <basicUdiDi>B-HU5101005LC</basicUdiDi>
    <tradeName>D-HU5101005LC</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5101005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:58:24.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5101004LA</udiDi>
    <basicUdiDi>B-HU5101004LA</basicUdiDi>
    <tradeName>D-HU5101004LA</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5101004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:58:23.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73621HN</udiDi>
    <basicUdiDi>B-73621HN</basicUdiDi>
    <tradeName>AUTION Sticks 10PA</tradeName>
    <deviceName>AUTION Sticks 10PA</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73621</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:01.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73601HG</udiDi>
    <basicUdiDi>B-73601HG</basicUdiDi>
    <tradeName>AUTION SCREEN Microalbumin/Creatinine</tradeName>
    <deviceName>AUTION SCREEN Microalbumin/Creatinine</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73601</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:43.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73597JJ</udiDi>
    <basicUdiDi>B-73597JJ</basicUdiDi>
    <tradeName>Uriflet S 9UB</tradeName>
    <deviceName>Uriflet S 9UB</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73597</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:42.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73594JC</udiDi>
    <basicUdiDi>B-73594JC</basicUdiDi>
    <tradeName>AUTION Sticks 10EA</tradeName>
    <deviceName>AUTION Sticks 10EA</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73594</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:38.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73591J6</udiDi>
    <basicUdiDi>B-73591J6</basicUdiDi>
    <tradeName>AUTION Sticks 10EA</tradeName>
    <deviceName>AUTION Sticks 10EA</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73591</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:37.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73524HP</udiDi>
    <basicUdiDi>B-73524HP</basicUdiDi>
    <tradeName>AUTION Sticks 10PA</tradeName>
    <deviceName>AUTION Sticks 10PA</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>73524</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:30.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73521HH</udiDi>
    <basicUdiDi>B-73521HH</basicUdiDi>
    <tradeName>Uriflet S 9HA</tradeName>
    <deviceName>Uriflet S 9HA</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73521</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:30.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73520HF</udiDi>
    <basicUdiDi>B-73520HF</basicUdiDi>
    <tradeName>Uriflet S 10HB</tradeName>
    <deviceName>Uriflet S 10HB</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73520</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:29.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73519HW</udiDi>
    <basicUdiDi>B-73519HW</basicUdiDi>
    <tradeName>Uriflet S 10HA</tradeName>
    <deviceName>Uriflet S 10HA</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73519</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:26.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-23905GG</udiDi>
    <basicUdiDi>B-23905GG</basicUdiDi>
    <tradeName>Uriflet S 9UB</tradeName>
    <deviceName>Uriflet S 9UB</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23905</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:38:16.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20286FJ</udiDi>
    <basicUdiDi>B-20286FJ</basicUdiDi>
    <tradeName>AUTION Sticks 10EA</tradeName>
    <deviceName>AUTION Sticks 10EA</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>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20286</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:05.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>16925794573664</udiDi>
    <basicUdiDi>B-16925794573664</basicUdiDi>
    <tradeName>Urinalysis Strips</tradeName>
    <deviceName>Urinalysis Strips</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008626</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:55:15.374Z</lastUpdated>
  </row>
</eudamedExport>