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<eudamedExport entity="devices">
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    <udiDi>06936268412344</udiDi>
    <basicUdiDi>B-06936268412344</basicUdiDi>
    <tradeName>06936268412344</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TIANJIN EMPECS MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000036494</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>1016912</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:27:56.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935784450007</udiDi>
    <basicUdiDi>B-06935784450007</basicUdiDi>
    <tradeName>06935784450007</tradeName>
    <deviceName></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 Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M11</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:41.230Z</lastUpdated>
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  <row>
    <udiDi>06934175005598</udiDi>
    <basicUdiDi>B-06934175005598</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</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>1N002DD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:36.352Z</lastUpdated>
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  <row>
    <udiDi>06934175004591</udiDi>
    <basicUdiDi>B-06934175004591</basicUdiDi>
    <tradeName>Safe AQ proⅠ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</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>5Y001DD</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:29.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175004584</udiDi>
    <basicUdiDi>B-06934175004584</basicUdiDi>
    <tradeName>Safe AQ max Ⅲ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</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>6D001DD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:27.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>06914329008729</udiDi>
    <basicUdiDi>B-06914329008729</basicUdiDi>
    <tradeName>06914329008729</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Yicheng Bioelectronics Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033130</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>System（5D-1）：113010013、System（5D-2）：113020010、System（5D-3）：113030014、System（5D-6）：113040014、System（5D-8B）：113070018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T12:46:25.788Z</lastUpdated>
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  <row>
    <udiDi>06914329008668</udiDi>
    <basicUdiDi>B-06914329008668</basicUdiDi>
    <tradeName>06914329008668</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Yicheng Bioelectronics Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033130</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>113010012、113020009、113030013、113040013、113050009、113070017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T12:46:24.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902802701978</udiDi>
    <basicUdiDi>B-05902802701978</basicUdiDi>
    <tradeName>GluNEO plus Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFCN001LPO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:28:23.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719869705938</udiDi>
    <basicUdiDi>B-04719869705938</basicUdiDi>
    <tradeName>Spengler JT100 Blood Glucose Test Strips (50T) (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:14.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719869705921</udiDi>
    <basicUdiDi>B-04719869705921</basicUdiDi>
    <tradeName>Spengler JT100 Control Solution (Level 2) (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:13.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719869705914</udiDi>
    <basicUdiDi>B-04719869705914</basicUdiDi>
    <tradeName>Spengler JT100 Blood Glucose Monitoring System (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:12.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719869704153</udiDi>
    <basicUdiDi>B-04719869704153</basicUdiDi>
    <tradeName>JS100 Blood Glucose Test Strips (50T) (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JS100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:12.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719869704115</udiDi>
    <basicUdiDi>B-04719869704115</basicUdiDi>
    <tradeName>JS100 Blood Glucose Monitoring System (Standard Plus) (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JS100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:11.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711200724257</udiDi>
    <basicUdiDi>B-04711200724257</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-250063</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:52.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711200722376</udiDi>
    <basicUdiDi>B-04711200722376</basicUdiDi>
    <tradeName>GL GoodLife 001 Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-250031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:33.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711200722109</udiDi>
    <basicUdiDi>B-04711200722109</basicUdiDi>
    <tradeName>GlucoLeader Enhance 2 Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3K-01-250081 / 3K-01-250082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:30.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711200721621</udiDi>
    <basicUdiDi>B-04711200721621</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-160037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:27.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115900975</udiDi>
    <basicUdiDi>B-08809115900975</basicUdiDi>
    <tradeName>Oh'Care Lite Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFCH003A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:21:04.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809115905420</udiDi>
    <basicUdiDi>B-08809115905420</basicUdiDi>
    <tradeName>Oh'Care Lite Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFSS003A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:17:49.743Z</lastUpdated>
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  <row>
    <udiDi>08809115908285</udiDi>
    <basicUdiDi>B-08809115908285</basicUdiDi>
    <tradeName>GluNEO Lite Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFCL001L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:16:37.657Z</lastUpdated>
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</eudamedExport>