BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Injection box of EGRIFTA SV 2 mg/vial

    Reg #: 3011453824 · FEI: 3011453824 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    THERATECHNOLOGIES INC.
    Registration Number
    3011453824
    FEI Number
    3011453824
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2015 Peel Street, Suite 1100
    City
    Montreal Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K941562

    Owner / Operator

    Firm Name
    Theratechnologies Inc.
    Operator Number
    10062736
    Address
    2015 Peel Street, Suite 1100
    City
    Montreal
    State
    Quebec
    Postal Code
    H3A1T8
    Country
    CA
    Correspondent
    Harley Cunha

    US Agent

    Business Name
    Icon Clinical Research
    Contact Name
    Jamie Harris
    Address
    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
    Syringe, Piston FMF

    Proprietary Names

    Injection box of EGRIFTA SV 2 mg/vial

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device