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<eudamedExport entity="devices">
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    <udiDi>04260163315564</udiDi>
    <basicUdiDi>B-04260163315564</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card (5 tests per box, NL)</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07AG6005BSNL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:39:32.297Z</lastUpdated>
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  <row>
    <udiDi>04260163315557</udiDi>
    <basicUdiDi>B-04260163315557</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card (8 tests per box)</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07AG6008BS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:39:28.289Z</lastUpdated>
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  <row>
    <udiDi>04260163315540</udiDi>
    <basicUdiDi>B-04260163315540</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card (7 tests per box)</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07AG6007BS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:39:27.495Z</lastUpdated>
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  <row>
    <udiDi>04260163315533</udiDi>
    <basicUdiDi>B-04260163315533</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card (1 test per box NL)</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07AG6001BSNL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:39:26.693Z</lastUpdated>
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  <row>
    <udiDi>04260163315526</udiDi>
    <basicUdiDi>B-04260163315526</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card (5 tests per box)</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07AG6005BS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:39:25.892Z</lastUpdated>
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  <row>
    <udiDi>04260163315519</udiDi>
    <basicUdiDi>B-04260163315519</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card (1 Test Box)</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07AG6001BS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:39:21.894Z</lastUpdated>
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  <row>
    <udiDi>04260163315502</udiDi>
    <basicUdiDi>B-04260163315502</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card (20 tests per box)</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07AG6020BS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:39:21.092Z</lastUpdated>
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  <row>
    <udiDi>08800111725746</udiDi>
    <basicUdiDi>88001117ISCA01QA032G</basicUdiDi>
    <tradeName>STANDARD™ Q COVID-19 Ag Home Test</tradeName>
    <deviceName>STANDARD™ Q COVID-19 Ag Home Test</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-03G/ 09COV130</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:07:08.076Z</lastUpdated>
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  <row>
    <udiDi>08800111725753</udiDi>
    <basicUdiDi>88001117ISCA01QA032G</basicUdiDi>
    <tradeName>STANDARD™ Q COVID-19 Ag Home Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-03G/ 09COV130H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:06:14.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111725760</udiDi>
    <basicUdiDi>88001117ISCA01QA032G</basicUdiDi>
    <tradeName>STANDARD™ Q COVID-19 Ag Home Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-03G/ 09COV130J</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:06:14.504Z</lastUpdated>
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  <row>
    <udiDi>08800111725777</udiDi>
    <basicUdiDi>88001117ISCA01QA032G</basicUdiDi>
    <tradeName>STANDARD™ Q COVID-19 Ag Home Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-03G/ 09COV130D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:06:14.411Z</lastUpdated>
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  <row>
    <udiDi>69743840304312</udiDi>
    <basicUdiDi>B-69743840304312</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021902</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:01.214Z</lastUpdated>
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  <row>
    <udiDi>69743840304244</udiDi>
    <basicUdiDi>B-69743840304244</basicUdiDi>
    <tradeName>COVID-19 IgG IgM Rapid Test Kit</tradeName>
    <deviceName>COVID-19 IgG IgM Rapid Test Kit</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090502</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIBODY (AB) - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:00.062Z</lastUpdated>
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  <row>
    <udiDi>D-697424646COVAB000FL5QW</udiDi>
    <basicUdiDi>B-697424646COVAB000FL5QW</basicUdiDi>
    <tradeName>COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)</tradeName>
    <deviceName>COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV Ab-4012F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:04:34.904Z</lastUpdated>
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  <row>
    <udiDi>D-697424646COVAG000FMUVL</udiDi>
    <basicUdiDi>B-697424646COVAG000FMUVL</basicUdiDi>
    <tradeName>COVID-19 Antigen FIA Test (Swab)</tradeName>
    <deviceName>COVID-19 Antigen FIA Test (Swab)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV Ag-6012F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:04:33.404Z</lastUpdated>
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    <udiDi>D-697424646COVAB001FL8RB</udiDi>
    <basicUdiDi>B-697424646COVAB001FL8RB</basicUdiDi>
    <tradeName>COVID-19 IgG/IgM FIA Test (Serum/Plasma)</tradeName>
    <deviceName>COVID-19 IgG/IgM FIA Test (Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV Ab-3012F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:04:32.016Z</lastUpdated>
  </row>
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    <udiDi>D-5N40C5ZK</udiDi>
    <basicUdiDi>B-5N40C5ZK</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Test (FIA)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5N40C5-20-EU, 5N40C5-40-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:07:24.335Z</lastUpdated>
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    <udiDi>06976232252088</udiDi>
    <basicUdiDi>B-06976232252088</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Covid-19 Antigen Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA03-50-422P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:32.439Z</lastUpdated>
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    <udiDi>08800111715778</udiDi>
    <basicUdiDi>88001117IPBA04QA04YQ</basicUdiDi>
    <tradeName>08800111715778</tradeName>
    <deviceName>STANDARD™ Q COVID-19 Ag Test 2.0</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-07G/ 09COV176D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:41:44.925Z</lastUpdated>
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    <udiDi>08800111715761</udiDi>
    <basicUdiDi>88001117IPBA02QA04Y2</basicUdiDi>
    <tradeName>08800111715761</tradeName>
    <deviceName>STANDARD™ Q COVID-19 Ag Test 2.0</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-07G/ 09COV175D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:41:42.521Z</lastUpdated>
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</eudamedExport>