BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    SpectoMED

    Reg #: 3038136320 · FEI: 3038136320 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SPECTO MEDICAL AG
    Registration Number
    3038136320
    FEI Number
    3038136320
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Elisabethenstrasse 18
    City
    Basel Basel-Stadt
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K242205

    Owner / Operator

    Firm Name
    Specto Medical AG
    Operator Number
    10093004
    Address
    Elisabethenstrasse 18
    City
    Basel
    State
    Basel-Stadt
    Postal Code
    4051
    Country
    CH
    Correspondent
    Charly Leprince

    US Agent

    Business Name
    Specto Medical USA LLC
    Contact Name
    Scott Mallett
    Address
    2626 Glenwood Avenue, Suite 500
    City
    Raleigh
    State
    NC
    ZIP
    27608
    Country
    US
    Email
    [email protected]
    Phone
    984 3006352

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    SpectoMED

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device