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    <basicUdiDi>B-100476LR</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</tradeName>
    <deviceName>GLUCOCARD X-mini plus (GT-1960)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>100476</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:36:23.151Z</lastUpdated>
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    <udiDi>D-100475LP</udiDi>
    <basicUdiDi>B-100475LP</basicUdiDi>
    <tradeName>GLUCOCARD X-mini plus (GT-1960)</tradeName>
    <deviceName>GLUCOCARD X-mini plus (GT-1960)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>100475</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:36:21.794Z</lastUpdated>
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    <udiDi>08809301168486</udiDi>
    <basicUdiDi>B-08809301168486</basicUdiDi>
    <tradeName>Gmate® Blood Glucose Test Strips</tradeName>
    <deviceName>Gmate® Blood Glucose Test Strip</deviceName>
    <manufacturerName>GB Lifecare Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039508</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>PS004-INT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:39:37.397Z</lastUpdated>
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    <udiDi>08809115908780</udiDi>
    <basicUdiDi>B-08809115908780</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>INFM001ASK</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:00:40.277Z</lastUpdated>
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  <row>
    <udiDi>08809115908377</udiDi>
    <basicUdiDi>B-08809115908377</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>INFM21APT</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:00:36.056Z</lastUpdated>
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  <row>
    <udiDi>08809115908520</udiDi>
    <basicUdiDi>B-08809115908520</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>INFM16B</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:00:33.804Z</lastUpdated>
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  <row>
    <udiDi>08809115908247</udiDi>
    <basicUdiDi>B-08809115908247</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>INFCN003APT</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:00:15.194Z</lastUpdated>
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  <row>
    <udiDi>08809115907561</udiDi>
    <basicUdiDi>B-08809115907561</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>INFM22ASV</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:00:09.590Z</lastUpdated>
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  <row>
    <udiDi>08809115907066</udiDi>
    <basicUdiDi>B-08809115907066</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>INFS22ARU</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:55.986Z</lastUpdated>
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  <row>
    <udiDi>08809115906830</udiDi>
    <basicUdiDi>B-08809115906830</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>INFCH003K</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:55.177Z</lastUpdated>
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  <row>
    <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>
    <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>INFS001LBG</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:44.799Z</lastUpdated>
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  <row>
    <udiDi>08809115905291</udiDi>
    <basicUdiDi>B-08809115905291</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>INFSS16B</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:59:42.370Z</lastUpdated>
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  <row>
    <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>
  </row>
  <row>
    <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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  <row>
    <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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  <row>
    <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>08809115900760</udiDi>
    <basicUdiDi>B-08809115900760</basicUdiDi>
    <tradeName>CLOVER A1c Self Analyzer</tradeName>
    <deviceName>CLOVER A1c Self 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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFH01AS2</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:57:00.909Z</lastUpdated>
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  <row>
    <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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</eudamedExport>