<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-FIHSA-102aHG2F</udiDi>
    <basicUdiDi>B-FIHSA-102aHG2F</basicUdiDi>
    <tradeName>MAU Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIHSA-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:29:13.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIHSA-102a3D</udiDi>
    <basicUdiDi>B-FIHSA-102a3D</basicUdiDi>
    <tradeName>MAU Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>MAU Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIHSA-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:28:55.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73806J4</udiDi>
    <basicUdiDi>B-73806J4</basicUdiDi>
    <tradeName>AUTION Control Solution</tradeName>
    <deviceName>AUTION Control Solution</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>73806</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:14.941Z</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-73527HV</udiDi>
    <basicUdiDi>B-73527HV</basicUdiDi>
    <tradeName>AUTION CHECK Plus</tradeName>
    <deviceName>AUTION CHECK Plus</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73527</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:31.672Z</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-47136487608BURS3Q</udiDi>
    <basicUdiDi>B-47136487608BURS3Q</basicUdiDi>
    <tradeName>Eclipse PLUS</tradeName>
    <deviceName>Eclipse PLUS Urine Control Solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5800401 S5800402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:18.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487608BCRTYV</udiDi>
    <basicUdiDi>B-47136487608BCRTYV</basicUdiDi>
    <tradeName>Eclipse PLUS</tradeName>
    <deviceName>Eclipse PLUS Creatinine Reagent Kit</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5641012 S5641013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:16.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487608BACRT2W</udiDi>
    <basicUdiDi>B-47136487608BACRT2W</basicUdiDi>
    <tradeName>Eclipse PLUS</tradeName>
    <deviceName>Eclipse PLUS ACR Reagent Kit</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5641014 S5641015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:12.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487608B06P</udiDi>
    <basicUdiDi>B-47136487608B06P</basicUdiDi>
    <tradeName>Eclipse PLUS</tradeName>
    <deviceName>Eclipse PLUS Multi-Purpose Analyzer</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S35010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:11.695Z</lastUpdated>
  </row>
</eudamedExport>