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    <manufacturerName>77 Elektronika Műszeripari Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000004266</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <reference>STR-9904</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:04.052Z</lastUpdated>
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    <udiDi>05997345782225</udiDi>
    <basicUdiDi>59973457DEK7V</basicUdiDi>
    <tradeName>Dcont ETALON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>77 Elektronika Műszeripari Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000004266</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D71-800100</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:03.696Z</lastUpdated>
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    <udiDi>05997345782263</udiDi>
    <basicUdiDi>59973457DEK7V</basicUdiDi>
    <tradeName>Dcont NOVUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>77 Elektronika Műszeripari Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000004266</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D72-800300</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:03.672Z</lastUpdated>
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    <udiDi>05997345782270</udiDi>
    <basicUdiDi>59973457DEK7V</basicUdiDi>
    <tradeName>Dcont ETALON B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>77 Elektronika Műszeripari Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000004266</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D73-800200</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:03.649Z</lastUpdated>
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    <udiDi>05997345782850</udiDi>
    <basicUdiDi>59973457DEV8K</basicUdiDi>
    <tradeName>Dcont NOVUM Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>77 Elektronika Műszeripari Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-PR-000004110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D72-9903</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:03.608Z</lastUpdated>
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    <udiDi>05997345782867</udiDi>
    <basicUdiDi>59973457DEV8K</basicUdiDi>
    <tradeName>Dcont ETALON B Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>77 Elektronika Műszeripari Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-PR-000004110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D73-9901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:03.587Z</lastUpdated>
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    <udiDi>05997345782874</udiDi>
    <basicUdiDi>59973457DEV8K</basicUdiDi>
    <tradeName>Dcont ROLL Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>77 Elektronika Műszeripari Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-PR-000004110</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D75-9901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:03.565Z</lastUpdated>
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    <udiDi>05060181540028</udiDi>
    <basicUdiDi>B-05060181540028</basicUdiDi>
    <tradeName>Agamatrix Wavesense Jazz Wireless meter</tradeName>
    <deviceName>Agamatrix Wavesense Jazz Wireless meter</deviceName>
    <manufacturerName>AgaMatrix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039145</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W020106019085</emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8000-10409</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:23:37.113Z</lastUpdated>
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    <udiDi>04713945681796</udiDi>
    <basicUdiDi>B-04713945681796</basicUdiDi>
    <tradeName>EASYMAX® Tag  Self Monitoring Blood Glucose System</tradeName>
    <deviceName>EASYMAX® Tag  Self Monitoring Blood Glucose System</deviceName>
    <manufacturerName>EPS Bio Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000028384</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>681.79</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:02:12.879Z</lastUpdated>
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  <row>
    <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>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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  <row>
    <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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  <row>
    <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>06944904052144</udiDi>
    <basicUdiDi>69449040AB3000012ZG</basicUdiDi>
    <tradeName>Automated Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H50P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:28.259Z</lastUpdated>
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    <udiDi>D-01A0212Y2</udiDi>
    <basicUdiDi>B-01A0212Y2</basicUdiDi>
    <tradeName>D-01A0212Y2</tradeName>
    <deviceName>Blood Glucose and Uric Acid Meter</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>4B001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:46.894Z</lastUpdated>
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    <udiDi>D-01A0111XT</udiDi>
    <basicUdiDi>B-01A0111XT</basicUdiDi>
    <tradeName>D-01A0111XT</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5Y001, 5Z001, 6A001, 6B001, 6C001, 6D001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:42.895Z</lastUpdated>
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    <udiDi>D-01A0206Y7</udiDi>
    <basicUdiDi>B-01A0206Y7</basicUdiDi>
    <tradeName>D-01A0206Y7</tradeName>
    <deviceName>Blood Glucose and Uric Acid Meter</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1V001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:42.090Z</lastUpdated>
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    <udiDi>D-01A0101XQ</udiDi>
    <basicUdiDi>B-01A0101XQ</basicUdiDi>
    <tradeName>D-01A0101XQ</tradeName>
    <deviceName>Blood Glucose Meter</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:22.033Z</lastUpdated>
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    <udiDi>09120131770014</udiDi>
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    <tradeName>GENSPEED R2 Analyzer</tradeName>
    <deviceName>GENSPEED R2 Analyzer</deviceName>
    <manufacturerName>GENSPEED Biotech</manufacturerName>
    <manufacturerSrn>AT-MF-000013008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>GSHW001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:59:33.482Z</lastUpdated>
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    <tradeName>08809408861969</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sugentech, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023952</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>IFFD001E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:38.409Z</lastUpdated>
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