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<eudamedExport entity="devices">
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    <udiDi>D-CNMF000014455HP-M51-GBQ</udiDi>
    <basicUdiDi>B-CNMF000014455HP-M51-GBQ</basicUdiDi>
    <tradeName>D-CNMF000014455HP-M51-GBQ</tradeName>
    <deviceName>Automated Glycohemoglobin 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>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-M51-G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:13:28.001Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000014455-A1C-M41L8</udiDi>
    <basicUdiDi>B-CNMF000014455-A1C-M41L8</basicUdiDi>
    <tradeName>D-CNMF000014455-A1C-M41L8</tradeName>
    <deviceName>A1cChek Express Glycohemoglobin 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>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-M41</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:11.734Z</lastUpdated>
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    <udiDi>D-47136487600B05F</udiDi>
    <basicUdiDi>B-47136487600B05F</basicUdiDi>
    <tradeName>Eclipse A1C</tradeName>
    <deviceName>Eclipse A1C Hemoglobin A1c POC analyzer</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S54133, S54144, S54145, S54119</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:09.199Z</lastUpdated>
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    <udiDi>D-4-76V</udiDi>
    <basicUdiDi>B-4-76V</basicUdiDi>
    <tradeName>D-4-76V</tradeName>
    <deviceName>Hemoglobin Meter</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:16.074Z</lastUpdated>
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  <row>
    <udiDi>16935784411074</udiDi>
    <basicUdiDi>B-16935784411074</basicUdiDi>
    <tradeName>16935784411074</tradeName>
    <deviceName>A1cChek Express Glycohemoglobin 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>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-M42</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:58:01.245Z</lastUpdated>
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  <row>
    <udiDi>16935784410015</udiDi>
    <basicUdiDi>B-16935784410015</basicUdiDi>
    <tradeName>16935784410015</tradeName>
    <deviceName>Glycohemoglobin 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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-M22</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:58.852Z</lastUpdated>
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  <row>
    <udiDi>16935784410008</udiDi>
    <basicUdiDi>B-16935784410008</basicUdiDi>
    <tradeName>16935784410008</tradeName>
    <deviceName>Glycohemoglobin 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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-M21</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:57:57.243Z</lastUpdated>
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  <row>
    <udiDi>14560189283432</udiDi>
    <basicUdiDi>B-14560189283432</basicUdiDi>
    <tradeName>14560189283432</tradeName>
    <deviceName>G7 HSi Elution Buffer No.3 (S)</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0019546</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:04:07.712Z</lastUpdated>
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  <row>
    <udiDi>14560189283425</udiDi>
    <basicUdiDi>B-14560189283425</basicUdiDi>
    <tradeName>14560189283425</tradeName>
    <deviceName>G7 HSi Elution Buffer No.2 (S)</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0019545</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:04:06.909Z</lastUpdated>
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  <row>
    <udiDi>14560189283418</udiDi>
    <basicUdiDi>B-14560189283418</basicUdiDi>
    <tradeName>14560189283418</tradeName>
    <deviceName>G7 HSi Elution Buffer No.1 (S)</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0019544</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:04:02.906Z</lastUpdated>
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  <row>
    <udiDi>08809115900760</udiDi>
    <basicUdiDi>B-08809115900760</basicUdiDi>
    <tradeName>CLOVER A1c Self Analyzer</tradeName>
    <deviceName>CLOVER A1c Self Analyzer</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFH01AS2</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:00.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065164004</udiDi>
    <basicUdiDi>B-08800065164004</basicUdiDi>
    <tradeName>CERA-STAT™ 2000  Analyzer</tradeName>
    <deviceName>Glycated Hemoglobin Measuring Analyzer</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CS200M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:15.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065162406</udiDi>
    <basicUdiDi>B-08800065162406</basicUdiDi>
    <tradeName>LabonaCheck™ A1c HbA1c Analyzer</tradeName>
    <deviceName>Glycated Hemoglobin Measuring Analyzer</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MH200M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:14.440Z</lastUpdated>
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    <udiDi>06978189071019</udiDi>
    <basicUdiDi>B-06978189071019</basicUdiDi>
    <tradeName>06978189071019</tradeName>
    <deviceName>Hemoglobin A1c(HbA1c) Panel (Microfluidic Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Yantai JIEZI Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:42:02.896Z</lastUpdated>
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    <udiDi>06973861683955</udiDi>
    <basicUdiDi>B-06973861683955</basicUdiDi>
    <tradeName>06973861683955</tradeName>
    <deviceName>HbA1c Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</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>A02017002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:42:34.692Z</lastUpdated>
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    <udiDi>06944904052144</udiDi>
    <basicUdiDi>69449040AB3000012ZG</basicUdiDi>
    <tradeName>Automated Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H50P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:28.259Z</lastUpdated>
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    <udiDi>08809328960872</udiDi>
    <basicUdiDi>880932896EMBCMT01BL</basicUdiDi>
    <tradeName>ASUREQUAN Analyzer</tradeName>
    <deviceName>ASUREQUAN Analyzer</deviceName>
    <manufacturerName>EMPECS Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000029619</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMBCMT01-EN01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:35.910Z</lastUpdated>
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    <udiDi>08809115902542</udiDi>
    <basicUdiDi>880911590IGM0026BMUN</basicUdiDi>
    <tradeName>HemoCue HbA1c 501 Analyzer</tradeName>
    <deviceName>HemoCue HbA1c 501 Analyzer</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>405210</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:45:12.404Z</lastUpdated>
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    <udiDi>08800323059646</udiDi>
    <basicUdiDi>880911590IGM0023MLQ</basicUdiDi>
    <tradeName>CLOVER A1c Analyzer</tradeName>
    <deviceName>CLOVER A1c Analyzer</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>89500</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:42:50.605Z</lastUpdated>
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    <udiDi>08800323058496</udiDi>
    <basicUdiDi>880911590IHM0005MM5</basicUdiDi>
    <tradeName>CLOVER A1c Expert Analyzer</tradeName>
    <deviceName>CLOVER A1c Expert Analyzer</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OHHS03A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:42:49.007Z</lastUpdated>
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