BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Us2.v1

    Reg #: 3017425832 · FEI: 3017425832 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EKO.AI PTE. LTD.
    Registration Number
    3017425832
    FEI Number
    3017425832
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 College Road, # 02-00
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K210791

    Owner / Operator

    Firm Name
    eko.ai pte. ltd.
    Operator Number
    10080906
    Address
    2 College Road, # 02-00
    City
    Singapore
    State
    SG-NOTA
    Postal Code
    169850
    Country
    SG
    Correspondent
    James Hare

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Us2.v1

    Establishment Types

    Manufacture Medical Device