<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-BK-SU1AQ</udiDi>
    <basicUdiDi>B-BK-SU1AQ</basicUdiDi>
    <tradeName>BeneCheck Supreme Uric Acid Test Strip</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-SU1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:42.607Z</lastUpdated>
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  <row>
    <udiDi>D-47136487613AUT3C</udiDi>
    <basicUdiDi>B-47136487613AUT3C</basicUdiDi>
    <tradeName>MultiSure</tradeName>
    <deviceName>MultiSure Uric Acid Test Strip</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5640832 S5640833</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:08.787Z</lastUpdated>
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  <row>
    <udiDi>D-47136487606AHT2F</udiDi>
    <basicUdiDi>B-47136487606AHT2F</basicUdiDi>
    <tradeName>HemoSmart GOLD</tradeName>
    <deviceName>HemoSmart GOLD hemoglobin test strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5640254, S5640365,  S5640733, S5640255, S5640682, S5640745</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:10.899Z</lastUpdated>
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  <row>
    <udiDi>D-47136487605AUT3F</udiDi>
    <basicUdiDi>B-47136487605AUT3F</basicUdiDi>
    <tradeName>UASure II</tradeName>
    <deviceName>UASure II Blood uric acid test strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5640955, S5640956</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:50.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800075500588</udiDi>
    <basicUdiDi>B-08800075500588</basicUdiDi>
    <tradeName>1drop™ TBIL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>1drop Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026103</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>B20190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:22:39.477Z</lastUpdated>
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  <row>
    <udiDi>07640402710119</udiDi>
    <basicUdiDi>B-07640402710119</basicUdiDi>
    <tradeName>FORA 6</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S057321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:10.971Z</lastUpdated>
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  <row>
    <udiDi>07640143658725</udiDi>
    <basicUdiDi>B-07640143658725</basicUdiDi>
    <tradeName>FORA 6 Uric Acid Test Strip</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:58:00.993Z</lastUpdated>
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  <row>
    <udiDi>07640143657919</udiDi>
    <basicUdiDi>B-07640143657919</basicUdiDi>
    <tradeName>FORA 6 Uric Acid Test Strip</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:57:27.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640143650217</udiDi>
    <basicUdiDi>B-07640143650217</basicUdiDi>
    <tradeName>FORA 6 Uric Acid Test Strip</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS057</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:56:48.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519630359</udiDi>
    <basicUdiDi>B-06975519630359</basicUdiDi>
    <tradeName>Vivadiag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS-103-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:32:55.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068491265</udiDi>
    <basicUdiDi>B-06975068491265</basicUdiDi>
    <tradeName>Blood Lipid Test Strip (Dry Chemistry )</tradeName>
    <deviceName>Blood Lipid Test Strip (Dry Chemistry )</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CP115.B1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:32:23.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068491258</udiDi>
    <basicUdiDi>B-06975068491258</basicUdiDi>
    <tradeName>Renal Function Test Strip (Dry Chemistry )</tradeName>
    <deviceName>Renal Function Test Strip (Dry Chemistry )</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CP114.B1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:32:19.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971404131376</udiDi>
    <basicUdiDi>B-06971404131376</basicUdiDi>
    <tradeName>ACCUGENCE®</tradeName>
    <deviceName>ACCUGENCE Hemoglobin Test Strips</deviceName>
    <manufacturerName>e-LinkCare Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019475</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM5112012</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:56:54.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804837112</udiDi>
    <basicUdiDi>B-06952804837112</basicUdiDi>
    <tradeName>06952804837112</tradeName>
    <deviceName>Blood β-Ketone Test Strips</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C904005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:53.844Z</lastUpdated>
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  <row>
    <udiDi>06952804837099</udiDi>
    <basicUdiDi>B-06952804837099</basicUdiDi>
    <tradeName>06952804837099</tradeName>
    <deviceName>Hemoglobin Test Strips</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C905005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:53.817Z</lastUpdated>
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  <row>
    <udiDi>04719893236958</udiDi>
    <basicUdiDi>B-04719893236958</basicUdiDi>
    <tradeName>NOVAMA® PRO MultiCheck+ 5w1 BT WIELOPARAMETROWY MIERNIK KRWI PASKI TESTOWE KWAS MOCZOWY</tradeName>
    <deviceName>Uric Acid Test Strips</deviceName>
    <manufacturerName>TaiDoc Technology Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000017956</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-4653</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:07:08.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-01B0212YD</udiDi>
    <basicUdiDi>B-01B0212YD</basicUdiDi>
    <tradeName>D-01B0212YD</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4B003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:59.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-01B0206YJ</udiDi>
    <basicUdiDi>B-01B0206YJ</basicUdiDi>
    <tradeName>D-01B0206YJ</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1V003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:57.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339207739</udiDi>
    <basicUdiDi>B-06937339207739</basicUdiDi>
    <tradeName>Hemoglobin Testing System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VOM01-013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:55:26.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339207722</udiDi>
    <basicUdiDi>B-06937339207722</basicUdiDi>
    <tradeName>Hemoglobin Testing System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VOM01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:55:25.356Z</lastUpdated>
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</eudamedExport>