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    <deviceName>AccuSure Life Plus  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>
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    <reference>VGM02-0Y2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:23:22.803Z</lastUpdated>
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    <tradeName>ITALO  M</tradeName>
    <deviceName>ITALO  M</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCIM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:58:32.380Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
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    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>VCHEMY S® EVO</tradeName>
    <deviceName>VCHEMY S® EVO</deviceName>
    <manufacturerName>Chengdu Seamaty Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033937</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVO-A01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:24.362Z</lastUpdated>
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    <tradeName>VEGA</tradeName>
    <deviceName>VEGA</deviceName>
    <manufacturerName>Chengdu Seamaty Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033937</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010499</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSIS / ELECTROLYTE INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VEGA-001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:23.566Z</lastUpdated>
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    <tradeName>Cleaner</tradeName>
    <deviceName>Cleaner</deviceName>
    <manufacturerName>EKF-diagnostic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-6232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:56:51.659Z</lastUpdated>
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    <udiDi>00630414482163</udiDi>
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    <tradeName>RAPIDPoint® 500 Systems Wash/Waste Cartridge (4)</tradeName>
    <deviceName>IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RapidPoint</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040185</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10329097</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:54:36.270Z</lastUpdated>
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    <manufacturerName>EKF-diagnostic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>3000-6233</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:48:59.080Z</lastUpdated>
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    <tradeName>Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKF-diagnostic GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>3000-6235</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:48:58.877Z</lastUpdated>
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    <udiDi>06937339210906</udiDi>
    <basicUdiDi>B-06937339210906</basicUdiDi>
    <tradeName>AccuSure  Life Plus  Blood Glucose Monitoring System</tradeName>
    <deviceName>AccuSure  Life Plus  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>VGM02-0Y1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:50:10.597Z</lastUpdated>
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    <udiDi>06937339210760</udiDi>
    <basicUdiDi>B-06937339210760</basicUdiDi>
    <tradeName>Klinion Blood Glucose meter</tradeName>
    <deviceName>Klinion 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>C047063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:50:06.591Z</lastUpdated>
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    <udiDi>06937339210753</udiDi>
    <basicUdiDi>B-06937339210753</basicUdiDi>
    <tradeName>Klinion Blood Glucose meter</tradeName>
    <deviceName>Klinion 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>C047061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:50:05.801Z</lastUpdated>
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    <udiDi>06937339210746</udiDi>
    <basicUdiDi>B-06937339210746</basicUdiDi>
    <tradeName>Klinion Blood Glucose meter</tradeName>
    <deviceName>Klinion 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>C047062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:50:05.021Z</lastUpdated>
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    <udiDi>06937339210715</udiDi>
    <basicUdiDi>B-06937339210715</basicUdiDi>
    <tradeName>Klinion Blood Glucose meter</tradeName>
    <deviceName>Klinion Blood Glucose meter</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C047060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:59.393Z</lastUpdated>
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    <tradeName>P-score Web Service (PWS)</tradeName>
    <deviceName>P-score Web Service (PWS)</deviceName>
    <manufacturerName>Prostatype Genomics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013349</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030192</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG0004</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:00:37.238Z</lastUpdated>
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    <tradeName>Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90</tradeName>
    <deviceName>Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90</deviceName>
    <manufacturerName>Suzhou Astrabio Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041763</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8901000100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:00:10.826Z</lastUpdated>
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    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Dry Fluorescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Suzhou Astrabio Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041763</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <emdnCode>W0201069099</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>8900018200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:00:10.039Z</lastUpdated>
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    <deviceName>Dxcover Control Pack</deviceName>
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    <manufacturerSrn>UK-MF-000046906</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
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    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DXC-CM-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:53:52.098Z</lastUpdated>
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    <tradeName>Atellica HA1C_E High Volume Conversion Kit</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_KIT_HA1C_E HIGH VOLUME CONVERSION KIT</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11470732</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:54.527Z</lastUpdated>
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    <tradeName>Atellica Lid Keying Feature</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_KIT_LID KEYING FEATURE KIT</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>11597266</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:53.739Z</lastUpdated>
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