BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EDM IMAGING USA LLC

    Reg #: 3013369910 · FEI: 3013369910 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EDM IMAGING USA LLC
    Registration Number
    3013369910
    FEI Number
    3013369910
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4081 Sw 47th Ave Ste 10
    City
    Davie
    State
    FL
    ZIP
    33314
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082815

    Owner / Operator

    Firm Name
    EDM Imaging USA LLC
    Operator Number
    10056408
    Address
    4081 SW 47th Avenue, Suite 10
    City
    Davie
    State
    FL
    Postal Code
    33314
    Country
    US
    Correspondent
    Benjamin El Koubi

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility