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    <manufacturerName>SD Biosensor Inc.</manufacturerName>
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    <reference>10FA24</reference>
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    <udiDi>08800111723865</udiDi>
    <basicUdiDi>88001117IPAA01FA03UM</basicUdiDi>
    <tradeName>STANDARD™ F2400 Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-06-20T17:04:43.828Z</lastUpdated>
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    <udiDi>08800111723872</udiDi>
    <basicUdiDi>88001117IPAA01FA03UM</basicUdiDi>
    <tradeName>STANDARD™ F2400 Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnCode>W0201069099</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>08809115900357</udiDi>
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    <tradeName>CLOVER A1c Expert Analyzer</tradeName>
    <deviceName></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></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:56:38.430Z</lastUpdated>
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    <udiDi>08809115900494</udiDi>
    <basicUdiDi>880911590IHM0005MM5</basicUdiDi>
    <tradeName>CLOVER A1c Expert Analyzer</tradeName>
    <deviceName></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></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:56:38.401Z</lastUpdated>
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    <udiDi>08809115901446</udiDi>
    <basicUdiDi>880911590IHM0005MM5</basicUdiDi>
    <tradeName>CLOVER A1c Expert Analyzer</tradeName>
    <deviceName></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></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:56:22.781Z</lastUpdated>
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    <udiDi>08809115902467</udiDi>
    <basicUdiDi>880911590IHM0005MM5</basicUdiDi>
    <tradeName>CLOVER A1c Expert Analyzer</tradeName>
    <deviceName></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></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:56:22.623Z</lastUpdated>
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    <udiDi>04719871870242</udiDi>
    <basicUdiDi>471987187CHR63XYUA</basicUdiDi>
    <tradeName>RAPID TEST READER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KAIWOOD Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000043631</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHR-636</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:50:37.094Z</lastUpdated>
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    <udiDi>04719869705938</udiDi>
    <basicUdiDi>B-04719869705938</basicUdiDi>
    <tradeName>Spengler JT100 Blood Glucose Test Strips (50T) (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:14.760Z</lastUpdated>
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    <udiDi>04719869705921</udiDi>
    <basicUdiDi>B-04719869705921</basicUdiDi>
    <tradeName>Spengler JT100 Control Solution (Level 2) (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:13.864Z</lastUpdated>
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    <udiDi>04719869705914</udiDi>
    <basicUdiDi>B-04719869705914</basicUdiDi>
    <tradeName>Spengler JT100 Blood Glucose Monitoring System (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:12.968Z</lastUpdated>
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    <udiDi>04719869704153</udiDi>
    <basicUdiDi>B-04719869704153</basicUdiDi>
    <tradeName>JS100 Blood Glucose Test Strips (50T) (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JS100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:12.054Z</lastUpdated>
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    <udiDi>04719869704115</udiDi>
    <basicUdiDi>B-04719869704115</basicUdiDi>
    <tradeName>JS100 Blood Glucose Monitoring System (Standard Plus) (CE)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JS100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-18T12:47:11.193Z</lastUpdated>
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    <udiDi>04711200724257</udiDi>
    <basicUdiDi>B-04711200724257</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-250063</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:52.929Z</lastUpdated>
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    <udiDi>04711200722376</udiDi>
    <basicUdiDi>B-04711200722376</basicUdiDi>
    <tradeName>GL GoodLife 001 Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-250031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:33.124Z</lastUpdated>
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    <udiDi>04711200722109</udiDi>
    <basicUdiDi>B-04711200722109</basicUdiDi>
    <tradeName>GlucoLeader Enhance 2 Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3K-01-250081 / 3K-01-250082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:30.431Z</lastUpdated>
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    <udiDi>04711200721621</udiDi>
    <basicUdiDi>B-04711200721621</basicUdiDi>
    <tradeName>GlucoLeader Enhance Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-160037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:27.741Z</lastUpdated>
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    <basicUdiDi>B-04260658552702</basicUdiDi>
    <tradeName>AtlasvDrabkins Reagent, 40x, 50ml/vial (500 Tests)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.02.46.1.0500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:56.049Z</lastUpdated>
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    <basicUdiDi>B-08809115900975</basicUdiDi>
    <tradeName>Oh'Care Lite Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFCH003A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:21:04.636Z</lastUpdated>
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    <basicUdiDi>B-08809115905420</basicUdiDi>
    <tradeName>Oh'Care Lite Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFSS003A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-17T02:17:49.743Z</lastUpdated>
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