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<eudamedExport entity="devices">
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    <udiDi>08806128322008</udiDi>
    <basicUdiDi>88061283AGM2200KDY</basicUdiDi>
    <tradeName>GlucoDr.SuperSensor™ Blood Glucose Monitoring System</tradeName>
    <deviceName>AGM-2200 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-2200-K1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:41.532Z</lastUpdated>
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    <udiDi>08806128320066</udiDi>
    <basicUdiDi>88061283AGM2200ME4</basicUdiDi>
    <tradeName>GlucoDr.SuperSensor™ Blood Glucose Test Meter</tradeName>
    <deviceName>AGM-2200 Blood Glucose Test Meter</deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-2200-M1-P1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:37.528Z</lastUpdated>
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  <row>
    <udiDi>08806128310586</udiDi>
    <basicUdiDi>88061283AGM2100KDR</basicUdiDi>
    <tradeName>GlucoDr.™ Blood Glucose Monitoring System</tradeName>
    <deviceName>AGM-2100 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-2100-K1-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:35.132Z</lastUpdated>
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    <udiDi>08806128310562</udiDi>
    <basicUdiDi>88061283AGM2100MDV</basicUdiDi>
    <tradeName>GlucoDr.™ Blood Glucose Test Meter</tradeName>
    <deviceName>AGM-2100 Blood Glucose Test Meter</deviceName>
    <manufacturerName>All Medicus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020833</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGM-2100-M1-P1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:59:31.142Z</lastUpdated>
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    <udiDi>08800065166008</udiDi>
    <basicUdiDi>88000651HAAHM000C8</basicUdiDi>
    <tradeName>CERA-STAT™ 4000 Analyzer</tradeName>
    <deviceName>CERA-STAT™ 4000 Analyzer</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</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>CS400M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:58:47.115Z</lastUpdated>
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  <row>
    <udiDi>08684595032268</udiDi>
    <basicUdiDi>868459503MH57</basicUdiDi>
    <tradeName>Micro Heater Incubator</tradeName>
    <deviceName>Mini Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMH1001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:28:54.365Z</lastUpdated>
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    <udiDi>08684595032251</udiDi>
    <basicUdiDi>868459503FIAProMiniR3</basicUdiDi>
    <tradeName>FIAPro™ Mini Immunofluorescence Analyzer</tradeName>
    <deviceName>Mini Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMFIA1006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:28:52.763Z</lastUpdated>
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  <row>
    <udiDi>00810173654708</udiDi>
    <basicUdiDi>81649002OG-H10189</basicUdiDi>
    <tradeName>Mini Immunofluorescence Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-H101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:19:45.723Z</lastUpdated>
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  <row>
    <udiDi>00810173653022</udiDi>
    <basicUdiDi>81017365OG-G2604E</basicUdiDi>
    <tradeName>Multiplex Fluorescent Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:19:44.916Z</lastUpdated>
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  <row>
    <udiDi>06972337851591</udiDi>
    <basicUdiDi>697233785GHgbA010ME</basicUdiDi>
    <tradeName>06972337851591</tradeName>
    <deviceName>Glycated Hemoglobin Analyzer</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G20</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:31:47.404Z</lastUpdated>
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  <row>
    <udiDi>06971771200194</udiDi>
    <basicUdiDi>69717712001948N</basicUdiDi>
    <tradeName>Multi-function analyzer (blood glucose, uric acid, lipids, blood pressure)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GULP-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:21:53.126Z</lastUpdated>
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    <udiDi>06936983171526</udiDi>
    <basicUdiDi>6970277510020LYB</basicUdiDi>
    <tradeName>06936983171526</tradeName>
    <deviceName>Uric Acid Meter</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>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AUAR-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:12:53.731Z</lastUpdated>
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  <row>
    <udiDi>06936983164825</udiDi>
    <basicUdiDi>6970277510019RZD</basicUdiDi>
    <tradeName>Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II</tradeName>
    <deviceName>Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II</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>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGKUCR-200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:12:48.118Z</lastUpdated>
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  <row>
    <udiDi>06936983164795</udiDi>
    <basicUdiDi>6970277510019QZB</basicUdiDi>
    <tradeName>Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I</tradeName>
    <deviceName>Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system Ⅰ</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>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGKUCR-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:12:47.329Z</lastUpdated>
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    <udiDi>06944904052137</udiDi>
    <basicUdiDi>69449040AB3000012ZG</basicUdiDi>
    <tradeName>Automated Glycohemoglobin Analyzer</tradeName>
    <deviceName>Automated Glycohemoglobin Analyzer</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>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:54:08.598Z</lastUpdated>
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    <udiDi>06939184631516</udiDi>
    <basicUdiDi>6939184630001BD</basicUdiDi>
    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Bioland Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010625</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-427B</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:11:20.105Z</lastUpdated>
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    <udiDi>06934175010684</udiDi>
    <basicUdiDi>6934175001A0620P3</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Hemoglobin Analyzer</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:04:40.455Z</lastUpdated>
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    <udiDi>06933260209064</udiDi>
    <basicUdiDi>69332602IT01000029T</basicUdiDi>
    <tradeName>FIA Analyzer FLI-100</tradeName>
    <deviceName>FIA Analyzer FLI-100</deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0106</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:36.724Z</lastUpdated>
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    <udiDi>06933260209088</udiDi>
    <basicUdiDi>69332602IT01000049X</basicUdiDi>
    <tradeName>FIA Analyzer BIOT-YG-I</tradeName>
    <deviceName>FIA Analyzer BIOT-YG-I</deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0104</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:36.693Z</lastUpdated>
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    <udiDi>06934175010691</udiDi>
    <basicUdiDi>6934175001A0620P3</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName></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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:55:05.874Z</lastUpdated>
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