BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    PROLLENIUM MEDICAL TECHNOLOGIES INC.

    Reg #: 3004423487 · FEI: 3004423487 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    5
    Classifications
    3

    Registration Details

    Registration Name
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Registration Number
    3004423487
    FEI Number
    3004423487
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    138 Industrial Pkwy N.
    City
    Aurora Ontario
    Country
    CA

    Regulatory Submissions

    PMA Number
    P160042

    Owner / Operator

    Firm Name
    Prollenium Medical Technologies Inc.
    Operator Number
    10055618
    Address
    138 Industrial Pkwy N.
    City
    Aurora
    State
    Ontario
    Postal Code
    L4G4C3
    Country
    CA
    Correspondent
    Denis Vezina

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Implant, Dermal, For Aesthetic Use LMH
    Cannula, Surgical, General & Plastic Surgery GEA
    Pack, Hot Or Cold, Reusable IME

    Proprietary Names

    Revanesse Versa Revanesse Versa+ with Lidocaine Revanesse Versa+ with Lidocaine 1.2 mL Revanesse® Lips™ + with Lidocaine 1.2 mL Revanesse® Lips™ + with Lidocaine Revanesse® Versa™ 1.2 mL SoftFil® Precision SoftFil® EasyGuide Revanesse Gel Pack

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility