BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    EKO.AI PTE. LTD.

    Reg #: 3017425832 · FEI: 3017425832 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EKO.AI PTE. LTD.
    Registration Number
    3017425832
    FEI Number
    3017425832
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    163 Tras Street, #09-04 Lian Huat Building
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K210791

    Owner / Operator

    Firm Name
    eko.ai pte. ltd.
    Operator Number
    10080906
    Address
    163 Tras Street, #09-04 Lian Huat Building
    City
    Singapore
    State
    SG-NOTA
    Postal Code
    079024
    Country
    SG
    Correspondent
    James Hare

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    Adjunctive Cardiac Amyloidosis Status Indicator SDJ

    Proprietary Names

    Us2.v1 Us2.v2 Viz Echocardiogram AI Measurements Viz Cardiac Amyloidosis AI Detection Us2.ca

    Establishment Types

    Manufacture Medical Device