BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    SmoothSkin Pure

    Reg #: 3004635398 · FEI: 3004635398 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CYDEN LIMITED
    Registration Number
    3004635398
    FEI Number
    3004635398
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Block A, Bay Studios Business Park, Fabian Way
    City
    SWANSEA, WALES
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K200184

    Owner / Operator

    Firm Name
    CYDEN LIMITED
    Operator Number
    9060768
    Address
    Block A, Bay Studios Buisness Park, Fabian Way,
    City
    SWANSEA
    State
    GB-NOTA
    Postal Code
    SA1 8QB
    Country
    GB
    Correspondent
    MARK STEPHENS

    US Agent

    Business Name
    METRO-PACK INC
    Contact Name
    JOHN SGOMBICK
    Address
    37 JEANNE DRIVE, NEWBURGH
    City
    Newburgh
    State
    NY
    ZIP
    12550
    Country
    US
    Email
    [email protected]
    Phone
    845 5645275

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Light Based Over-The-Counter Hair Removal OHT

    Proprietary Names

    SmoothSkin Pure

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility