BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOOKA INC.

    Reg #: 3007671445 · FEI: 3007671445 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    SOOKA INC.
    Registration Number
    3007671445
    FEI Number
    3007671445
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    102 NE 2nd Street, Ste 137
    City
    Boca Raton
    State
    FL
    ZIP
    33432
    Country
    US

    Regulatory Submissions

    510(k) Number
    K012964

    Owner / Operator

    Firm Name
    Sooka Inc.
    Operator Number
    10033614
    Address
    102 NE 2nd Street, #137
    City
    Boca Raton
    State
    FL
    Postal Code
    33432
    Country
    US
    Correspondent
    Kimberly Ardwell

    Products

    Device Name Product Code
    Condom HIS

    Proprietary Names

    GLYDE GLYDE Condom

    Establishment Types

    Repack or Relabel Medical Device