<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-6909620WHSFOB8VJY</udiDi>
    <basicUdiDi>B-6909620WHSFOB8VJY</basicUdiDi>
    <tradeName>One-Step Immunological  Fecal Occult Blood Test</tradeName>
    <deviceName>Occult Blood Tests</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-FOB-S0x0101; WH-FOB-S0x0102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:02.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-H2SR</udiDi>
    <basicUdiDi>B-BK-H2SR</basicUdiDi>
    <tradeName>BeneCheck Hb Hemoglobin Test Strip</tradeName>
    <deviceName>Hb Hemoglobin 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>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-H2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:35.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490708TB</udiDi>
    <basicUdiDi>B-4260152490708TB</basicUdiDi>
    <tradeName>Haemoglobin</tradeName>
    <deviceName>Photometer</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB 442A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:18:25.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490692TM</udiDi>
    <basicUdiDi>B-4260152490692TM</basicUdiDi>
    <tradeName>Hämoglobin Eck-Küvetten</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB 440A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:18:23.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490623T2</udiDi>
    <basicUdiDi>B-4260152490623T2</basicUdiDi>
    <tradeName>Hämoglobin 2500 ml Flasche</tradeName>
    <deviceName>Photometer</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB 2500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:18:20.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490616T5</udiDi>
    <basicUdiDi>B-4260152490616T5</basicUdiDi>
    <tradeName>Hämoglobin 500 mL Flasche</tradeName>
    <deviceName>Photometer</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB 500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:18:16.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490517T2</udiDi>
    <basicUdiDi>B-4260152490517T2</basicUdiDi>
    <tradeName>Hämoglobin Eckküvetten</tradeName>
    <deviceName>Photometer</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB 040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:18:14.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490128SK</udiDi>
    <basicUdiDi>B-4260152490128SK</basicUdiDi>
    <tradeName>Hämoglobin</tradeName>
    <deviceName>DP 350 / DP 550</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB 342</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:39.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490111S2</udiDi>
    <basicUdiDi>B-4260152490111S2</basicUdiDi>
    <tradeName>Hämoglobin</tradeName>
    <deviceName>DP 350 / DP 550</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB 142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:38.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037900814</udiDi>
    <basicUdiDi>B-08800037900814</basicUdiDi>
    <tradeName>08800037900814</tradeName>
    <deviceName>SimplexTAS 101 Hb Reagent Cartridge</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0101039</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:06:00.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978467910146</udiDi>
    <basicUdiDi>B-06978467910146</basicUdiDi>
    <tradeName>AllDx</tradeName>
    <deviceName>Hb Hemoglobin Test Strips</deviceName>
    <manufacturerName>Hangzhou Aokai Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048311</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S105-0011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:44:08.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519630014</udiDi>
    <basicUdiDi>B-06975519630014</basicUdiDi>
    <tradeName>Hemoglobin Test Strips</tradeName>
    <deviceName>Hemoglobin Test Strips</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-101-1</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:32:29.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598009516</udiDi>
    <basicUdiDi>B-04050598009516</basicUdiDi>
    <tradeName>PreventID® Haemo/HaptOccult</tradeName>
    <deviceName>PreventID® Haemo/HaptOccult</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST40112TP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:26.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008960</udiDi>
    <basicUdiDi>B-04050598008960</basicUdiDi>
    <tradeName>PreventID® CC</tradeName>
    <deviceName>PreventID® CC</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST40110GP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:01.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008205</udiDi>
    <basicUdiDi>B-04050598008205</basicUdiDi>
    <tradeName>PreventID® CC</tradeName>
    <deviceName>PreventID® CC</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST40110TP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:01.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008199</udiDi>
    <basicUdiDi>B-04050598008199</basicUdiDi>
    <tradeName>PreventID® CC</tradeName>
    <deviceName>PreventID® CC</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST40110EP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:00.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598003606</udiDi>
    <basicUdiDi>B-04050598003606</basicUdiDi>
    <tradeName>IDK® Hemoglobin (1-point-calibration) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin (1-point-calibration) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7836D.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:43:12.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598003583</udiDi>
    <basicUdiDi>B-04050598003583</basicUdiDi>
    <tradeName>IDK® Hemoglobin (human) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin (human) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7816D.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:43:11.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598001626</udiDi>
    <basicUdiDi>B-04050598001626</basicUdiDi>
    <tradeName>IDK® Hemoglobin/Haptoglobin Complex ELISA</tradeName>
    <deviceName>IDK® Hemoglobin/Haptoglobin Complex ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7817D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:55.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000742</udiDi>
    <basicUdiDi>B-04050598000742</basicUdiDi>
    <tradeName>IDK® Hemoglobin (1-point-calibration) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin (1-point-calibration) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7836D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:06.242Z</lastUpdated>
  </row>
</eudamedExport>