BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AEU-525 FAMILY

    Reg #: 3017604 · FEI: 3017604 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ASEPTICO, INC.
    Registration Number
    3017604
    FEI Number
    3017604
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8333 216th St SE
    City
    WOODINVILLE
    State
    WA
    ZIP
    98072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130693

    Owner / Operator

    Firm Name
    ASEPTICO, INC.
    Operator Number
    3017604
    Address
    8333 216TH ST., S.E., --
    City
    Woodinville
    State
    WA
    Postal Code
    98072
    Country
    US

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC
    Unit, Operative Dental EIA
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    AEU-525 FAMILY AEU-350 - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device