<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04712558762533</udiDi>
    <basicUdiDi>B-04712558762533</basicUdiDi>
    <tradeName>04712558762533</tradeName>
    <deviceName>eBchek Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Visgeneer Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000036547</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1320349</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T01:39:01.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712558762298</udiDi>
    <basicUdiDi>B-04712558762298</basicUdiDi>
    <tradeName>04712558762298</tradeName>
    <deviceName>eBwell Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Visgeneer Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000036547</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1320855</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T01:38:55.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712558760317</udiDi>
    <basicUdiDi>B-04712558760317</basicUdiDi>
    <tradeName>04712558760317</tradeName>
    <deviceName>eBfine Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Visgeneer Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000036547</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1320387</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T01:38:50.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175044252</udiDi>
    <basicUdiDi>6934175001A0104NC</basicUdiDi>
    <tradeName>FHhub</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10100853</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:47:22.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260315240065</udiDi>
    <basicUdiDi>B-04260315240065</basicUdiDi>
    <tradeName>Gluceofine Pro Blutzucker-Mess-System</tradeName>
    <deviceName>Gluceofine Pro Blutzucker-Mess-System</deviceName>
    <manufacturerName>TaiDoc Technology Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000017956</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-4183</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:52:39.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061027264436</udiDi>
    <basicUdiDi>5060599401942YP</basicUdiDi>
    <tradeName>Cholesterol Meter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RL-CHOM-1AS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:32.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984062822</udiDi>
    <basicUdiDi>6970341680120203GU</basicUdiDi>
    <tradeName>Hemoglobin Analyzer(HPLC)</tradeName>
    <deviceName>Hemoglobin Analyzer(HPLC)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:39:52.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350047030274</udiDi>
    <basicUdiDi>735004703NIOXSENSORG2</basicUdiDi>
    <tradeName>NIOX</tradeName>
    <deviceName>NIOX Sensor</deviceName>
    <manufacturerName>NIOX AB</manufacturerName>
    <manufacturerSrn>SE-MF-000010044</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069085</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-1630</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:35:54.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984062815</udiDi>
    <basicUdiDi>6970341680120203GU</basicUdiDi>
    <tradeName>Hemoglobin Analyzer(HPLC)</tradeName>
    <deviceName>Hemoglobin Analyzer(HPLC)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:29:39.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-M347S</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-M347S</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-M347S</tradeName>
    <deviceName>Multi Function Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-M34</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:48:09.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-M337Q</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-M337Q</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-M337Q</tradeName>
    <deviceName>Multi Function Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-M33</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:48:01.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-M327N</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-M327N</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-M327N</tradeName>
    <deviceName>Multi Function Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-M32</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:48:00.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-M227K</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-M227K</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-M227K</tradeName>
    <deviceName>Multi Function Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-M22</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:58.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-M217H</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-M217H</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-M217H</tradeName>
    <deviceName>Multi Function Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-330</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:56.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-M147L</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-M147L</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-M147L</tradeName>
    <deviceName>Multi Function Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-M14</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:50.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-M137J</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-M137J</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-M137J</tradeName>
    <deviceName>Multi Function Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-M13</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:49.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-M127G</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-M127G</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-M127G</tradeName>
    <deviceName>Multi Function Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-M12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:47:47.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697191378-MMQ8</udiDi>
    <basicUdiDi>B-697191378-MMQ8</basicUdiDi>
    <tradeName>ACCU-ANSWER</tradeName>
    <deviceName>Multi-Monitoring Meter</deviceName>
    <manufacturerName>Guilin Royalyze Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038422</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LBM-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:10.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69507155KFA06CHP</udiDi>
    <basicUdiDi>B-69507155KFA06CHP</basicUdiDi>
    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFA106</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:10.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69396639H6</udiDi>
    <basicUdiDi>B-69396639H6</basicUdiDi>
    <tradeName>Sejoy</tradeName>
    <deviceName>BG-709g Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG-709g</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:51:48.493Z</lastUpdated>
  </row>
</eudamedExport>