<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DGHB-R102acro75</udiDi>
    <basicUdiDi>B-DGHB-R102acro75</basicUdiDi>
    <tradeName>GHB Rapid Test Cassette (Urine)</tradeName>
    <deviceName>GHB Rapid Test Cassette (Urine)</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGHB-R102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:14.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046681171727</udiDi>
    <basicUdiDi>4046681151040VR</basicUdiDi>
    <tradeName>Medi-Test Combi 2</tradeName>
    <deviceName>Medi-Test URYXXON® Stick 10</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93015.004</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:58:41.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693748520UX</udiDi>
    <basicUdiDi>B-693748520UX</basicUdiDi>
    <tradeName>ACCU-ANSWER</tradeName>
    <deviceName>Urinary Analysis Test Strips</deviceName>
    <manufacturerName>Guilin Zhonghui Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038423</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Uric 10 CF, Uric 4VSG, Uric 2VGK, Uric 2VGP, Uric 3V, Uric 4V</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:34.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693748520-UGPD</udiDi>
    <basicUdiDi>B-693748520-UGPD</basicUdiDi>
    <tradeName>ACCU-ANSWER</tradeName>
    <deviceName>Urine Glucose Test Strips</deviceName>
    <manufacturerName>Guilin Zhonghui Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038423</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Uric</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:34.389Z</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-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>06976374752347</udiDi>
    <basicUdiDi>B-06976374752347</basicUdiDi>
    <tradeName>Urine Analysis Test Strips (Dry Chemistry Method)</tradeName>
    <deviceName>Urine Analysis Test Strips (Dry Chemistry Method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BH-14H  150strips/Kit(DR087-4)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:44:03.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752330</udiDi>
    <basicUdiDi>B-06976374752330</basicUdiDi>
    <tradeName>Urine Analysis Test Strips (Dry Chemistry Method)</tradeName>
    <deviceName>Urine Analysis Test Strips (Dry Chemistry Method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BH-14H  100 strips/Kit（DR087-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:44:01.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752309</udiDi>
    <basicUdiDi>B-06976374752309</basicUdiDi>
    <tradeName>Urine Analysis Test Strips (Dry Chemistry Method)</tradeName>
    <deviceName>Urine Analysis Test Strips (Dry Chemistry Method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BH-11H  100 strips/Kit（DR086-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:59.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752323</udiDi>
    <basicUdiDi>B-06976374752323</basicUdiDi>
    <tradeName>Urine Analysis Test Strips (Dry Chemistry Method)</tradeName>
    <deviceName>Urine Analysis Test Strips (Dry Chemistry Method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BH-14H  50 strips/Kit（DR087-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:57.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752316</udiDi>
    <basicUdiDi>B-06976374752316</basicUdiDi>
    <tradeName>Urine Analysis Test Strips (Dry Chemistry Method)</tradeName>
    <deviceName>Urine Analysis Test Strips (Dry Chemistry Method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BH-14H  10 strips/Kit（DR087-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:56.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752293</udiDi>
    <basicUdiDi>B-06976374752293</basicUdiDi>
    <tradeName>Urine Analysis Test Strips (Dry Chemistry Method)</tradeName>
    <deviceName>Urine Analysis Test Strips (Dry Chemistry Method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BH-11H  50 strips/Kit（DR086-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:55.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752286</udiDi>
    <basicUdiDi>B-06976374752286</basicUdiDi>
    <tradeName>Urine Analysis Test Strips (Dry Chemistry Method)</tradeName>
    <deviceName>Urine Analysis Test Strips (Dry Chemistry Method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BH-9H   100 strips/Kit（DR084）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:39.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804837068</udiDi>
    <basicUdiDi>B-06952804837068</basicUdiDi>
    <tradeName>06952804837068</tradeName>
    <deviceName>Uric Acid 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>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C903005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:48.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658552771</udiDi>
    <basicUdiDi>B-04260658552771</basicUdiDi>
    <tradeName>Atlas URS 1 Parameter: Ketone, 100 Strips/Bottle.</tradeName>
    <deviceName>Atlas URS 1 Parameter: Ketone, 100 Strips/Bottle.</deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.03.02.0.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:53:36.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850031753105</udiDi>
    <basicUdiDi>B-00850031753105</basicUdiDi>
    <tradeName>RapidBac™</tradeName>
    <deviceName>RapidBac™ Rapid Test for Detection of Bacteria - Pack of 10 Tests</deviceName>
    <manufacturerName>Silver Lake Research Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000027373</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>RB111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:55.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046681142802</udiDi>
    <basicUdiDi>4046681151057WA</basicUdiDi>
    <tradeName>Medi-Test Glucose BHR</tradeName>
    <deviceName>Medi-Test Glucose</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>93001.203880</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:17:00.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046681000003</udiDi>
    <basicUdiDi>4046681151040VR</basicUdiDi>
    <tradeName>Medi-Test Glucose</tradeName>
    <deviceName>Medi-Test URYXXON® Stick 10</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:16:35.103Z</lastUpdated>
  </row>
</eudamedExport>