BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    OPTELLUM LTD

    Reg #: 3015478020 · FEI: 3015478020 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OPTELLUM LTD
    Registration Number
    3015478020
    FEI Number
    3015478020
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Five Kings Meadow, Osney Mead
    City
    Oxford Oxfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K202300

    Owner / Operator

    Firm Name
    Optellum Ltd
    Operator Number
    10060418
    Address
    Five Kings Meadow, Osney Mead
    City
    Oxford
    State
    Oxfordshire
    Postal Code
    OX2 0DP
    Country
    GB

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK

    Proprietary Names

    Optellum software Optellum Virtual Nodule Clinic Optellum platform

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device