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    <tradeName>GluNEO Lite Blood Glucose Test Strip</tradeName>
    <deviceName>GluNEO Lite Blood Glucose Test Strip</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
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    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:52:15.887Z</lastUpdated>
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    <udiDi>04260423180062</udiDi>
    <basicUdiDi>B-04260423180062</basicUdiDi>
    <tradeName>GluNEO Lite Blood Glucose Control Solution (Low)</tradeName>
    <deviceName>GluNEO Lite Blood Glucose Control Solution (Low)</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
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    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:52:12.697Z</lastUpdated>
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    <udiDi>04260423180055</udiDi>
    <basicUdiDi>B-04260423180055</basicUdiDi>
    <tradeName>GluNEO Lite Blood Glucose Test Strip</tradeName>
    <deviceName>GluNEO Lite Blood Glucose Test Strip</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D48535</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:52:11.881Z</lastUpdated>
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    <udiDi>04260423180048</udiDi>
    <basicUdiDi>B-04260423180048</basicUdiDi>
    <tradeName>GluNEO Lite Blood Glucose Control Solution (Normal)</tradeName>
    <deviceName>GluNEO Lite Blood Glucose Control Solution (Normal)</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D48539</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:52:11.085Z</lastUpdated>
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    <udiDi>04260423180031</udiDi>
    <basicUdiDi>B-04260423180031</basicUdiDi>
    <tradeName>GluNEO Lite Blood Glucose Control Solution (High)</tradeName>
    <deviceName>GluNEO Lite Blood Glucose Control Solution (High)</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D48541</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:52:07.075Z</lastUpdated>
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    <udiDi>04260423180024</udiDi>
    <basicUdiDi>B-04260423180024</basicUdiDi>
    <tradeName>GluNEO Lite Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>GluNEO Lite Blood Glucose Monitoring System for self-testing</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>D48531</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:52:06.279Z</lastUpdated>
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  <row>
    <udiDi>04260235110349</udiDi>
    <basicUdiDi>B-04260235110349</basicUdiDi>
    <tradeName>adia Blood Glucose Control Solution (High)</tradeName>
    <deviceName>adia Blood Glucose Control Solution (High)</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:55.872Z</lastUpdated>
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  <row>
    <udiDi>04260235110165</udiDi>
    <basicUdiDi>B-04260235110165</basicUdiDi>
    <tradeName>adia Blood Glucose Control Solution (Low)</tradeName>
    <deviceName>adia Blood Glucose Control Solution (Low)</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21415</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:51.868Z</lastUpdated>
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    <udiDi>04260235110332</udiDi>
    <basicUdiDi>B-04260235110332</basicUdiDi>
    <tradeName>adia Blood Glucose Monitoring System for self-testing (mmol)</tradeName>
    <deviceName>adia Blood Glucose Monitoring System for self-testing (mmol)</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>21514</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:51.065Z</lastUpdated>
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    <udiDi>04260235110325</udiDi>
    <basicUdiDi>B-04260235110325</basicUdiDi>
    <tradeName>adia Blood Glucose Test Strip</tradeName>
    <deviceName>adia Blood Glucose Test Strip</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21467</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:50.268Z</lastUpdated>
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    <udiDi>04260235110172</udiDi>
    <basicUdiDi>B-04260235110172</basicUdiDi>
    <tradeName>GluNEO Lite Blood Glucose Test Strip</tradeName>
    <deviceName>GluNEO Lite Blood Glucose Test Strip</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>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21416</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:49.556Z</lastUpdated>
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    <udiDi>04260235110158</udiDi>
    <basicUdiDi>B-04260235110158</basicUdiDi>
    <tradeName>adia Blood Glucose Control Solution (Normal)</tradeName>
    <deviceName>adia Blood Glucose Control Solution (Normal)</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21414</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:34.014Z</lastUpdated>
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    <udiDi>04260235110141</udiDi>
    <basicUdiDi>B-04260235110141</basicUdiDi>
    <tradeName>adia Blood Glucose Monitoring System for self-testing (mg)</tradeName>
    <deviceName>adia Blood Glucose Monitoring System for self-testing (mg)</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>21499</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:33.374Z</lastUpdated>
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    <udiDi>04260072576513</udiDi>
    <basicUdiDi>B-04260072576513</basicUdiDi>
    <tradeName>GluNEO plus Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>GluNEO plus Blood Glucose Monitoring System for self-testing</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>INFS003KG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:48:29.190Z</lastUpdated>
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    <udiDi>04260072576506</udiDi>
    <basicUdiDi>B-04260072576506</basicUdiDi>
    <tradeName>GluNEO plus Blood Glucose Control Solution (High)</tradeName>
    <deviceName>GluNEO plus Blood Glucose Control Solution (High)</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFM003KG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:48:28.406Z</lastUpdated>
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    <udiDi>08809115902610</udiDi>
    <basicUdiDi>B-08809115902610</basicUdiDi>
    <tradeName>HemoCue HbA1c 501 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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>405210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:21:30.158Z</lastUpdated>
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    <udiDi>08809115902542</udiDi>
    <basicUdiDi>880911590IGM0026BMUN</basicUdiDi>
    <tradeName>HemoCue HbA1c 501 Analyzer</tradeName>
    <deviceName>HemoCue HbA1c 501 Analyzer</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>405210</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:45:12.404Z</lastUpdated>
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    <udiDi>08800323059646</udiDi>
    <basicUdiDi>880911590IGM0023MLQ</basicUdiDi>
    <tradeName>CLOVER A1c Analyzer</tradeName>
    <deviceName>CLOVER A1c Analyzer</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>89500</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:42:50.605Z</lastUpdated>
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    <udiDi>08800323058496</udiDi>
    <basicUdiDi>880911590IHM0005MM5</basicUdiDi>
    <tradeName>CLOVER A1c Expert Analyzer</tradeName>
    <deviceName>CLOVER A1c Expert Analyzer</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>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:42:49.007Z</lastUpdated>
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    <udiDi>08809115907134</udiDi>
    <basicUdiDi>B-08809115907134</basicUdiDi>
    <tradeName>CLOVER A1c Plus Test Cartridge</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OHHS03A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:25:05.850Z</lastUpdated>
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