<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970221762909</udiDi>
    <basicUdiDi>B-06970221762909</basicUdiDi>
    <tradeName>VivaChek Fad Blood Glucose Monitoring System</tradeName>
    <deviceName>VivaChek Fad Blood Glucose Monitoring System</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGM03-031</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:02.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970221762510</udiDi>
    <basicUdiDi>B-06970221762510</basicUdiDi>
    <tradeName>VivaChek Ino Blood Glucose Monitoring System</tradeName>
    <deviceName>VivaChek Ino Blood Glucose Monitoring System</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGM01-011</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:34:55.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970221762497</udiDi>
    <basicUdiDi>B-06970221762497</basicUdiDi>
    <tradeName>VivaChek FAD Blood Glucose Meter</tradeName>
    <deviceName>VivaChek FAD Blood Glucose Meter</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGM03-035</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:34:53.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970133920886</udiDi>
    <basicUdiDi>697013392001FC</basicUdiDi>
    <tradeName>06970133920886</tradeName>
    <deviceName>Automated Glycohemoglobin Analyzer AH-600</deviceName>
    <manufacturerName>Ailex Technology Group Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018920</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH-600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:45:11.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817701</udiDi>
    <basicUdiDi>B-06952804817701</basicUdiDi>
    <tradeName>Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip)</tradeName>
    <deviceName>Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip)</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EG-101，EG-102，EGS-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:46.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804813673</udiDi>
    <basicUdiDi>B-06952804813673</basicUdiDi>
    <tradeName>Hemoglobin Test Strips and Hemoglobin Meter</tradeName>
    <deviceName>Hemoglobin Test Strips and Hemoglobin Meter</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>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS-XH-02, HBM-W11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:27:48.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804812553</udiDi>
    <basicUdiDi>B-06952804812553</basicUdiDi>
    <tradeName>Blood Glucose Test Strips</tradeName>
    <deviceName>Blood Glucose 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>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C901005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:27:30.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715501030</udiDi>
    <basicUdiDi>B-06950715501030</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>KFA108</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:50.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500545</udiDi>
    <basicUdiDi>B-06950715500552</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>KFA105</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:19.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500521</udiDi>
    <basicUdiDi>B-06950715500545</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>KFA104</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:12.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500514</udiDi>
    <basicUdiDi>B-06950715500514</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>KFA102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:11.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500507</udiDi>
    <basicUdiDi>B-06950715500507</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>KFA110</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:09.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500491</udiDi>
    <basicUdiDi>B-06950715500491</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>KFA107</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:03.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500484</udiDi>
    <basicUdiDi>B-06950715500484</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>KFA103</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:03.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500477</udiDi>
    <basicUdiDi>B-06950715500477</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>KFA101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:01.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950715500460</udiDi>
    <basicUdiDi>B-06950715500460</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>KFA109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:55:00.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663988001</udiDi>
    <basicUdiDi>B-06939663988001</basicUdiDi>
    <tradeName>Blood Glucose Monitoring system</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG-707</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:05:21.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663971676</udiDi>
    <basicUdiDi>B-06939663971676</basicUdiDi>
    <tradeName>SEJOY Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG-203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:10.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663915571</udiDi>
    <basicUdiDi>B-06939663915571</basicUdiDi>
    <tradeName>SEJOY Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:08.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663912235</udiDi>
    <basicUdiDi>B-06939663912235</basicUdiDi>
    <tradeName>SEJOY Blood Glusose Monitoring system</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG-202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:06.587Z</lastUpdated>
  </row>
</eudamedExport>