BEUDAMED
    EU Manufacturer 🇺🇸 United States Active

    CTK Biotech Inc.

    SRN: US-MF-000024900 · Stowe Dr. 13855, 92064 Poway, United States
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    Basic UDI-DIs
    1
    Total Devices
    1
    On Market
    1
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Stowe Dr. 13855, 92064 Poway, United States
    Email
    [email protected]
    Phone
    +1 858 457 8698
    Website
    https://ctkbiotech.com/

    Regulatory Overview

    Regulation
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    Eu Ivdd 1
    Classification
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    Eu Ivd Annex 2 List A 1
    Device Types
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    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) No.2020-IVD/QS-008 May 26, 2024

    Market Presence

    Devices from this manufacturer are available in 1 country across Europe.

    🇩🇪 Germany

    Device Portfolio

    Name
    OnSite HIV 1/2 Ab Plus Combo Rapid Test