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    <tradeName>OneTouch SelectPlus Flex</tradeName>
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    <manufacturerName>LifeScan Europe GmbH</manufacturerName>
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    <tradeName>OneTouch Verio Flex</tradeName>
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    <manufacturerName>LifeScan Europe GmbH</manufacturerName>
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    <tradeName>OneTouch Verio Reflect</tradeName>
    <deviceName>OneTouch Verio Reflect</deviceName>
    <manufacturerName>LifeScan Europe GmbH</manufacturerName>
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    <authorisedRepresentativeName>LifeScan Deutschland GmbH</authorisedRepresentativeName>
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    <tradeName>OneTouch Verio Reflect</tradeName>
    <deviceName>OneTouch Verio Reflect</deviceName>
    <manufacturerName>LifeScan Europe GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000014224</manufacturerSrn>
    <authorisedRepresentativeName>LifeScan Deutschland GmbH</authorisedRepresentativeName>
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    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:50:14.438Z</lastUpdated>
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    <udiDi>07613427000152</udiDi>
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    <tradeName>OneTouch Verio Reflect</tradeName>
    <deviceName>OneTouch Verio Reflect</deviceName>
    <manufacturerName>LifeScan Europe GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000014224</manufacturerSrn>
    <authorisedRepresentativeName>LifeScan Deutschland GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Ek II Liste B</riskClass>
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    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>023909</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:50:13.547Z</lastUpdated>
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    <udiDi>07613427000015</udiDi>
    <basicUdiDi>B-07613427000015</basicUdiDi>
    <tradeName>OneTouch Verio Reflect</tradeName>
    <deviceName>OneTouch Verio Reflect</deviceName>
    <manufacturerName>LifeScan Europe GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000014224</manufacturerSrn>
    <authorisedRepresentativeName>LifeScan Deutschland GmbH</authorisedRepresentativeName>
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    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>023908</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <udiDi>07350047030205</udiDi>
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    <tradeName>NIOX VERO</tradeName>
    <deviceName>NIOX VERO</deviceName>
    <manufacturerName>NIOX AB</manufacturerName>
    <manufacturerSrn>SE-MF-000010044</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-1100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:16:12.612Z</lastUpdated>
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    <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>
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    <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>06975519630953</udiDi>
    <basicUdiDi>B-06975519630953</basicUdiDi>
    <tradeName>Dry Chemistry Analyzer</tradeName>
    <deviceName>Dry Chemistry Analyzer</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC-101-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:33:09.132Z</lastUpdated>
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    <udiDi>06975519630328</udiDi>
    <basicUdiDi>B-06975519630328</basicUdiDi>
    <tradeName>Lipid Testing System</tradeName>
    <deviceName>Lipid Testing System</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC-111-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:32:57.114Z</lastUpdated>
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    <udiDi>06975519630304</udiDi>
    <basicUdiDi>B-06975519630304</basicUdiDi>
    <tradeName>Lipid Testing System</tradeName>
    <deviceName>Lipid Testing System</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC-101-1</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:32:55.286Z</lastUpdated>
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    <udiDi>06974703168173</udiDi>
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    <tradeName>qLabs® ElectroMeter</tradeName>
    <deviceName>qLabs® ElectroMeter</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:29:33.288Z</lastUpdated>
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    <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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    <basicUdiDi>B-06972480914822</basicUdiDi>
    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Jiangxi Aicare Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025838</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
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    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:51:08.047Z</lastUpdated>
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    <basicUdiDi>B-06972480914624</basicUdiDi>
    <tradeName>Blood glucose meters</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Jiangxi Aicare Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025838</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
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    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Jiangxi Aicare Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025838</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>609010202</reference>
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    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Jiangxi Aicare Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025838</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
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    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Jiangxi Aicare Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025838</manufacturerSrn>
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    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Jiangxi Aicare Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025838</manufacturerSrn>
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    <tradeName>Blood Glucose Meter</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Jiangxi Aicare Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025838</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>W33010202</reference>
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    <lastUpdated>2026-07-06T11:50:36.002Z</lastUpdated>
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