BEUDAMED
    Eu Ivdd Eu Ivd Self Testing On The Market ๐Ÿ‡จ๐Ÿ‡ณ China

    Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)

    Acon Biotech (Hangzhou) Co., Ltd. ยท ๐Ÿ‡จ๐Ÿ‡ณ China
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    32
    Notified Bodies
    1

    Basic Information

    Primary DI
    D-L031-118R5ME
    Basic UDI-DI Code
    B-L031-118R5ME
    Reference
    L031-118R5
    Device Types
    Single use
    Regulation
    Eu Ivdd
    Classification
    Eu Ivd Self Testing
    Status
    On The Market
    Manufacturer
    Acon Biotech (Hangzhou) Co., Ltd.

    Additional Description

    The SARS-CoV-2 Antigen Rapid Test is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of the onset of symptoms. The test can also test specimens from individuals without symptoms. It is intended to be used for self-testing by lay users as an aid to diagnosis of SARS-CoV-2 infection.

    CND Nomenclature Codes

    Code Description
    W0105040619 CORONAVIRUS [obsolete from 2025-01-01]

    Certificates

    Type Number
    IVDD Annex III Section 6 V9 042074 0032

    Available In Countries

    ๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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