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    <tradeName>AccuSure Life Plus  Blood Glucose Meter</tradeName>
    <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>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGM02-0Y2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:23:22.803Z</lastUpdated>
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    <udiDi>06972337852369</udiDi>
    <basicUdiDi>697233785GHgbA010ME</basicUdiDi>
    <tradeName>06972337852369</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T22:48:04.586Z</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>
    <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>C047060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:59.393Z</lastUpdated>
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    <udiDi>06977100860190</udiDi>
    <basicUdiDi>697710086ASTDFL8</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>8900018200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:00:10.039Z</lastUpdated>
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    <udiDi>06935784460020</udiDi>
    <basicUdiDi>B-06935784460020</basicUdiDi>
    <tradeName>06935784460020</tradeName>
    <deviceName>Multi Function Immunofluorescence 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>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-M11</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:42.673Z</lastUpdated>
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    <udiDi>06935784460013</udiDi>
    <basicUdiDi>B-06935784460013</basicUdiDi>
    <tradeName>06935784460013</tradeName>
    <deviceName>Multi Function  Immunofluorescence 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>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-M31</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:38.693Z</lastUpdated>
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    <udiDi>06935784451028</udiDi>
    <basicUdiDi>B-06935784451028</basicUdiDi>
    <tradeName>06935784451028</tradeName>
    <deviceName>Blood Glucose Meter</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>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M73</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:37.864Z</lastUpdated>
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    <udiDi>06935784451011</udiDi>
    <basicUdiDi>B-06935784451011</basicUdiDi>
    <tradeName>06935784451011</tradeName>
    <deviceName>Blood Glucose Meter</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>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M72</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:37.065Z</lastUpdated>
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    <udiDi>06935784451004</udiDi>
    <basicUdiDi>B-06935784451004</basicUdiDi>
    <tradeName>06935784451004</tradeName>
    <deviceName>Blood Glucose Meter</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>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-M71</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:36.271Z</lastUpdated>
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    <udiDi>06934175049677</udiDi>
    <basicUdiDi>6934175001A0104NC</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Blood Glucose Meter</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10100846</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:08:58.569Z</lastUpdated>
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    <basicUdiDi>6934175001A0104NC</basicUdiDi>
    <tradeName>Sinocare</tradeName>
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    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
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    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14101618</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:07:01.302Z</lastUpdated>
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    <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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14101620</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:07:01.280Z</lastUpdated>
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    <basicUdiDi>6934175001A0104NC</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14101621</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:07:01.261Z</lastUpdated>
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    <basicUdiDi>6934175001A0104NC</basicUdiDi>
    <tradeName>Sinocare</tradeName>
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    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14101622</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:07:01.211Z</lastUpdated>
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    <udiDi>06934175049721</udiDi>
    <basicUdiDi>6934175001A0104NC</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10100849</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T12:07:01.195Z</lastUpdated>
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    <udiDi>04712558769778</udiDi>
    <basicUdiDi>B-04712558769778</basicUdiDi>
    <tradeName>04712558769778</tradeName>
    <deviceName>eBfresh Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Visgeneer Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000036547</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1320245</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T01:39:22.137Z</lastUpdated>
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