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    <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>
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    <reference>INFCH003K</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:55.177Z</lastUpdated>
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    <udiDi>08809115905949</udiDi>
    <basicUdiDi>B-08809115905949</basicUdiDi>
    <tradeName>Oh'Care Lite Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>Oh'Care 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>
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    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFS001LBG</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:44.799Z</lastUpdated>
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    <udiDi>08809115905291</udiDi>
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    <tradeName>FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</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>INFSS16B</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:42.370Z</lastUpdated>
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    <udiDi>08809115904188</udiDi>
    <basicUdiDi>B-08809115904188</basicUdiDi>
    <tradeName>FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>FINETEST Auto-coding premium 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>INFM16BICZ</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:55.388Z</lastUpdated>
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    <udiDi>08809115904164</udiDi>
    <basicUdiDi>B-08809115904164</basicUdiDi>
    <tradeName>EASYGLUCO Auto-coding Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>EASYGLUCO Auto-coding 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>INFM22ACZ</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:52.979Z</lastUpdated>
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    <udiDi>08809115901569</udiDi>
    <basicUdiDi>B-08809115901569</basicUdiDi>
    <tradeName>Gluco Check ExCEllent Blood Glucose Monitoring System for self-testing (mol)</tradeName>
    <deviceName>Gluco Check Excellent Blood Glucose Monitoring System for self-testing (mol)</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>INFS17BG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:20.108Z</lastUpdated>
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    <udiDi>08809115900890</udiDi>
    <basicUdiDi>B-08809115900890</basicUdiDi>
    <tradeName>GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>GLUCOLAB Auto-Coding 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>INFCL001A</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:07.295Z</lastUpdated>
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    <udiDi>08809115900876</udiDi>
    <basicUdiDi>B-08809115900876</basicUdiDi>
    <tradeName>GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>GLUCOLAB Auto-Coding 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>INFM001ACZ</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:05.697Z</lastUpdated>
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    <udiDi>08809115900814</udiDi>
    <basicUdiDi>B-08809115900814</basicUdiDi>
    <tradeName>GluNEO Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>GluNEO 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>INFM001A</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:01.697Z</lastUpdated>
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    <udiDi>08809115900739</udiDi>
    <basicUdiDi>B-08809115900739</basicUdiDi>
    <tradeName>ELEMENT Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>ELEMENT 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>INFM21ACZ</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:00.115Z</lastUpdated>
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    <udiDi>08809115900562</udiDi>
    <basicUdiDi>B-08809115900562</basicUdiDi>
    <tradeName>Gluco Check ExCEllent Blood Glucose Monitoring System for self-testing (mmol)</tradeName>
    <deviceName>Gluco Check Excellent 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>INFM17BG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:56:52.089Z</lastUpdated>
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    <udiDi>08809115900500</udiDi>
    <basicUdiDi>B-08809115900500</basicUdiDi>
    <tradeName>ELEMENT Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>ELEMENT 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>INFM21AGR</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:56:47.306Z</lastUpdated>
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    <udiDi>08809115900395</udiDi>
    <basicUdiDi>B-08809115900395</basicUdiDi>
    <tradeName>GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>GLUCOLAB Auto-Coding 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>INFM22A</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:56:46.482Z</lastUpdated>
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    <udiDi>08800323056164</udiDi>
    <basicUdiDi>B-08800323056164</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>INFSS001L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:22:42.507Z</lastUpdated>
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    <udiDi>08800323056140</udiDi>
    <basicUdiDi>B-08800323056140</basicUdiDi>
    <tradeName>GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>GLUCOLAB Auto-Coding 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>INFS22ANL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:22:40.918Z</lastUpdated>
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    <udiDi>08800065113019</udiDi>
    <basicUdiDi>B-08800065113019</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Blood Glucose, Hemoglobin, Lactate Monitoring System</tradeName>
    <deviceName>Blood Glucose, Hemoglobin, Lactate Monitoring System</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</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>M400M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:53.614Z</lastUpdated>
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    <udiDi>08800065110001</udiDi>
    <basicUdiDi>B-08800065110001</basicUdiDi>
    <tradeName>CERA-CHEK™ 1070 Blood Glucose Monitoring System</tradeName>
    <deviceName>CERA-CHEK™ 1070 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</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>G300M10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:49.644Z</lastUpdated>
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    <udiDi>08800065106004</udiDi>
    <basicUdiDi>B-08800065106004</basicUdiDi>
    <tradeName>CERA-CHEK™ 1Code Blood Glucose Monitoring System</tradeName>
    <deviceName>CERA-CHEK™ 1Code Blood Glucose Monitoring System</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G400M10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:48.816Z</lastUpdated>
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    <udiDi>08682328782008</udiDi>
    <basicUdiDi>B-08682328782008</basicUdiDi>
    <tradeName>Novacheck Blood Glucose Meter (Glucometer)</tradeName>
    <deviceName>Blood Glucose Meter (Glucometer)</deviceName>
    <manufacturerName>NOVATECH TIBBİ CİHAZ ÜRÜNLERİ SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000019017</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LM-602</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:22:58.708Z</lastUpdated>
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    <udiDi>08588008819036</udiDi>
    <basicUdiDi>B-08588008819036</basicUdiDi>
    <tradeName>Next PRO Glukomer</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>TaiDoc Technology Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000017956</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-4125</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:29:24.395Z</lastUpdated>
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