BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Easi-Vue™ embolic microspheres System

    Reg #: 3013505221 · FEI: 3013505221 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ABK BIOMEDICAL
    Registration Number
    3013505221
    FEI Number
    3013505221
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    155 Chain Lake Drive, Unit 32
    City
    Halifax Nova Scotia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K220567

    Owner / Operator

    Firm Name
    ABK Biomedical
    Operator Number
    10086030
    Address
    155 Chain Lake Drive, Unit 32
    City
    Halifax
    State
    Nova Scotia
    Postal Code
    B3S 1B3
    Country
    CA
    Correspondent
    Brandi Woods

    US Agent

    Business Name
    ABK Biomedical, Inc
    Contact Name
    Brandi Woods
    Address
    600 Park Offices Dr., Suite LL 75
    City
    Research Triangle Park
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    919 6196417

    Products

    Device Name Product Code
    Device, Vascular, For Promoting Embolization KRD

    Proprietary Names

    Easi-Vue™ embolic microspheres System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device