<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810047983477</udiDi>
    <basicUdiDi>0810047980001AG5</basicUdiDi>
    <tradeName>HB Hemoglobin Test Meter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHR-ACO100ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:13:42.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810186848484</udiDi>
    <basicUdiDi>0810047980001AG5</basicUdiDi>
    <tradeName>HB Hemoglobin Test Meter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHR-ACO100ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:13:42.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977338230277</udiDi>
    <basicUdiDi>697733823000CDG</basicUdiDi>
    <tradeName>06977338230277</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C61-HB100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:13:42.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810164510242</udiDi>
    <basicUdiDi>0810164510002N5</basicUdiDi>
    <tradeName>Hemoglubin Meter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aceso Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045175</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EKA01-HB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:03:54.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BSH01DBP</udiDi>
    <basicUdiDi>B-BSH01DBP</basicUdiDi>
    <tradeName>BeneCheck Uni Hemoglobin Monitoring System</tradeName>
    <deviceName>Hb hemoglobin test system</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>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSH01D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:33.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BSH010AH</udiDi>
    <basicUdiDi>B-BSH010AH</basicUdiDi>
    <tradeName>BeneCheck Uni Hemoglobin Monitoring System</tradeName>
    <deviceName>Hb hemoglobin test system</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>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSH010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:32.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519631172</udiDi>
    <basicUdiDi>B-06975519631172</basicUdiDi>
    <tradeName>Hemoglobin Testing System</tradeName>
    <deviceName>Hemoglobin Testing System</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-211-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:33:09.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519630052</udiDi>
    <basicUdiDi>B-06975519630052</basicUdiDi>
    <tradeName>Hemoglobin Testing System</tradeName>
    <deviceName>Hemoglobin testing system</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>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-111-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:32:32.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519630038</udiDi>
    <basicUdiDi>B-06975519630038</basicUdiDi>
    <tradeName>Hemoglobin Testing System</tradeName>
    <deviceName>Hemoglobin Testing System</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>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-101-1</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:32:31.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954417600114</udiDi>
    <basicUdiDi>6954417609073023</basicUdiDi>
    <tradeName>06954417600114</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Medconn Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038658</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:54:37.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954417600121</udiDi>
    <basicUdiDi>69544176150180YJ</basicUdiDi>
    <tradeName>06954417600121</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Medconn Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038658</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:54:00.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908015864094</udiDi>
    <basicUdiDi>8908015864HBCHEKMETER74</basicUdiDi>
    <tradeName>HbChek</tradeName>
    <deviceName>Hemoglobin Analyzer - HbChek Meter</deviceName>
    <manufacturerName>Biosense Technologies Private Limited.</manufacturerName>
    <manufacturerSrn>IN-MF-000052180</manufacturerSrn>
    <authorisedRepresentativeName>MD&amp;D Alliance GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045389</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG00061</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:07:24.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809446082135</udiDi>
    <basicUdiDi>880944608BAH0X0DW</basicUdiDi>
    <tradeName>08809446082135</tradeName>
    <deviceName>careSTART™ Hb1 Analyzer</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHN-E00182</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:13.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977367850033</udiDi>
    <basicUdiDi>697736785GHA001NZ</basicUdiDi>
    <tradeName>06977367850033</tradeName>
    <deviceName>Glycated  hemoglobin analyzer</deviceName>
    <manufacturerName>Changchun Chenyu Taikang Medical Laboratory Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000046653</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TG-10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:30:05.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519631165</udiDi>
    <basicUdiDi>6975519630005B5Q</basicUdiDi>
    <tradeName>06975519631165</tradeName>
    <deviceName>Hemoglobin Testing System</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-201-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:14:15.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070765484</udiDi>
    <basicUdiDi>697507076000317S4</basicUdiDi>
    <tradeName>Fully Automated CLIA Analyzer</tradeName>
    <deviceName>Fully Automated CLIA Analyzer</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18920001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:04:01.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070765477</udiDi>
    <basicUdiDi>697507076000316S2</basicUdiDi>
    <tradeName>Fully Automated CLIA Analyzer</tradeName>
    <deviceName>Fully Automated CLIA Analyzer</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18920002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:04:00.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260214044</udiDi>
    <basicUdiDi>69332602IT01000119U</basicUdiDi>
    <tradeName>06933260214044</tradeName>
    <deviceName>UAM-02 Uric Acid Monitoring System</deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0000901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:53:17.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260214037</udiDi>
    <basicUdiDi>69332602IT01000109S</basicUdiDi>
    <tradeName>06933260214037</tradeName>
    <deviceName>BKM-02 Blood Ketone Monitoring System</deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0000801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:53:17.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983105491</udiDi>
    <basicUdiDi>6970277510002SYM</basicUdiDi>
    <tradeName>Hb Hemoglobin Test Meter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02020699</emdnCode>
    <emdnDescription>RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHR-100ST</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:12.450Z</lastUpdated>
  </row>
</eudamedExport>