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    <tradeName>COVID-19 Antigen Rapid Test</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVID-19-B02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:19:52.005Z</lastUpdated>
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    <udiDi>86979834610580</udiDi>
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    <tradeName>COVID 19 Antigen Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>COVID 19 Antigen Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>OSMUNDA Medical Technology Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009285</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105090501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>15065023763037</udiDi>
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    <tradeName>TruVue</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:33:56.931Z</lastUpdated>
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    <udiDi>08806134664840</udiDi>
    <basicUdiDi>B-08806134664840</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:10:01.679Z</lastUpdated>
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    <udiDi>08806134664833</udiDi>
    <basicUdiDi>B-08806134664833</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:10:01.677Z</lastUpdated>
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    <udiDi>08806134664826</udiDi>
    <basicUdiDi>B-08806134664826</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:56.141Z</lastUpdated>
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    <udiDi>08806134664819</udiDi>
    <basicUdiDi>B-08806134664819</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:55.455Z</lastUpdated>
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    <udiDi>08806134664345</udiDi>
    <basicUdiDi>B-08806134664345</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:55.399Z</lastUpdated>
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    <udiDi>08806134664338</udiDi>
    <basicUdiDi>B-08806134664338</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:53.741Z</lastUpdated>
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    <udiDi>08806134664321</udiDi>
    <basicUdiDi>B-08806134664321</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:49.735Z</lastUpdated>
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    <udiDi>08806134664314</udiDi>
    <basicUdiDi>B-08806134664314</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:48.957Z</lastUpdated>
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    <udiDi>08806134601081</udiDi>
    <basicUdiDi>B-08806134601081</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:07:52.654Z</lastUpdated>
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    <udiDi>08806134601074</udiDi>
    <basicUdiDi>B-08806134601074</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:07:51.854Z</lastUpdated>
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    <udiDi>08806134601067</udiDi>
    <basicUdiDi>B-08806134601067</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:07:51.055Z</lastUpdated>
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    <udiDi>08806134601050</udiDi>
    <basicUdiDi>B-08806134601050</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>643K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:07:50.257Z</lastUpdated>
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    <basicUdiDi>B-08806134601043</basicUdiDi>
    <tradeName>GENEDIA W COVID-19 Ag</tradeName>
    <deviceName>GENEDIA W COVID-19 Ag</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>643K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:07:46.255Z</lastUpdated>
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    <udiDi>08800061800425</udiDi>
    <basicUdiDi>B-08800061800425</basicUdiDi>
    <tradeName>Allcheck COVID-19 Ag</tradeName>
    <deviceName>Allcheck COVID-19 Ag</deviceName>
    <manufacturerName>CALTH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000044697</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHR11</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:42.414Z</lastUpdated>
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    <tradeName>08693285186822</tradeName>
    <deviceName>Covid-19 Ag Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>TICV03105</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:31:41.229Z</lastUpdated>
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    <deviceName>Covid-19 Ag Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
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    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TICV03101</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:31:40.674Z</lastUpdated>
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    <deviceName>Covid-19 Ag Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
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    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TICV03125</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:31:40.338Z</lastUpdated>
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