BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Occlusin 500 Artificial Embolization Device

    Reg #: 3012120143 · FEI: 3012120143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    IMBIOTECHNOLOGIES LTD
    Registration Number
    3012120143
    FEI Number
    3012120143
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9650 20th Avenue, NW, Suite 215
    City
    Edmonton Alberta
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K093813

    Owner / Operator

    Firm Name
    IMBiotechnologies Ltd
    Operator Number
    10051764
    Address
    9650 20th Avenue, NW, Suite 215
    City
    Edmonton
    State
    Alberta
    Postal Code
    T6N 1G1
    Country
    CA
    Correspondent
    Michael Stewart

    US Agent

    Business Name
    ICON plc
    Contact Name
    Jamie Harris
    Address
    Icon Clinical Research, 731 Arbor Way Ste 100
    City
    Blue Bell
    State
    PA
    ZIP
    19422
    Country
    US
    Email
    [email protected]
    Phone
    661 6459048

    Products

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

    Proprietary Names

    Occlusin 500 Artificial Embolization Device Ekobi Embolization Microspheres

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device