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    <tradeName>Strep A Antigen Rapid Test</tradeName>
    <deviceName>Strep A Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <reference>P211116</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
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    <tradeName>FREND COVID-19 Ag</tradeName>
    <deviceName>FRCOG-J 020P</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <tradeName>FREND COVID-19 Ag</tradeName>
    <deviceName>FRCOG 020P</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
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    <tradeName>FREND COVID-19 Ag</tradeName>
    <deviceName>FRCOG-F 020P</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <reference>FRECOG-F 020P</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>08809317541082</udiDi>
    <basicUdiDi>B-08809317541082</basicUdiDi>
    <tradeName>FREND™ COVID-19 SP</tradeName>
    <deviceName>FRCOSW 020</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
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    <reference>FRCOSW 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:10.625Z</lastUpdated>
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    <udiDi>08809317541075</udiDi>
    <basicUdiDi>B-08809317541075</basicUdiDi>
    <tradeName>FREND™ COVID-19 Neutralization Ab</tradeName>
    <deviceName>FRCON 020</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRCON 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:09.792Z</lastUpdated>
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    <basicUdiDi>B-08809317541013</basicUdiDi>
    <tradeName>FREND™ COVID-19 Ag+FLU A&amp;B</tradeName>
    <deviceName>FRCGFL 020</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRCGFL 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:04.994Z</lastUpdated>
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    <tradeName>FREND™ COVID-19 SP</tradeName>
    <deviceName>FRCOS 020</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRCOS 020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:42:57.790Z</lastUpdated>
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    <basicUdiDi>B-08809317540924</basicUdiDi>
    <tradeName>FREND™ COVID-19 total Ab</tradeName>
    <deviceName>FRCOA 020</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRCOA 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:42:56.980Z</lastUpdated>
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    <udiDi>08809317540832</udiDi>
    <basicUdiDi>B-08809317540832</basicUdiDi>
    <tradeName>FREND™ COVID-19 IgG/IgM Duo</tradeName>
    <deviceName>FRCOD 020</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRCOD 020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:42:49.770Z</lastUpdated>
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    <udiDi>08684387213721</udiDi>
    <basicUdiDi>B-08684387213721</basicUdiDi>
    <tradeName>RevoDx BK/JC Virus qPCR Kit</tradeName>
    <deviceName>RevoDx BK/JC Virus qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202453-25</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:59:37.169Z</lastUpdated>
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    <udiDi>06976753475690</udiDi>
    <basicUdiDi>B-06976753475690</basicUdiDi>
    <tradeName>RSV Rapid Test Device (Swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A431301D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:20.315Z</lastUpdated>
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    <udiDi>06976753474754</udiDi>
    <basicUdiDi>B-06976753474754</basicUdiDi>
    <tradeName>AdenovirusRotavirus Combo Rapid Test Device(Feces)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A330401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:18.612Z</lastUpdated>
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    <udiDi>06975146600275</udiDi>
    <basicUdiDi>B-06975146600275</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00520</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:12.289Z</lastUpdated>
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    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T19:01:11.506Z</lastUpdated>
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    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:10.708Z</lastUpdated>
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    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:09.886Z</lastUpdated>
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    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:05.928Z</lastUpdated>
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    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00401</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:05.110Z</lastUpdated>
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    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00320</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:04.285Z</lastUpdated>
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