BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    HANSAmed Limited DBA Citagenix

    Reg #: 3004431266 · FEI: 3004431266 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    18

    Registration Details

    Registration Name
    HANSAmed Limited DBA Citagenix
    Registration Number
    3004431266
    FEI Number
    3004431266
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2830 Argentia Rd, Units 7-9
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K130235

    Owner / Operator

    Firm Name
    HANSAMED LIMITED dba CITAGENIX
    Operator Number
    9076685
    Address
    2830 Argentia Rd, Units 7-9
    City
    Mississauga
    State
    Ontario
    Postal Code
    L5N 8G4
    Country
    CA
    Correspondent
    Michael - McMillan

    US Agent

    Business Name
    Citagenix Regen LLC
    Contact Name
    Melody Stimbert
    Address
    51111 Pontiac Trl
    City
    Wixom
    State
    MI
    ZIP
    48393
    Country
    US
    Email
    [email protected]
    Phone
    248 2400386

    Products

    Device Name Product Code
    Wound Dressing With Animal-Derived Material(S) KGN
    Bone Grafting Material, Human Source NUN
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
    Barrier, Animal Source, Intraoral NPL
    Implant, Endosseous, Root-Form DZE
    Bit, Drill HTW
    Screwdriver HXX
    Bone Grafting Material, Animal Source NPM
    Tray, Surgical, Instrument FSM
    Syringe, Piston FMF
    Handpiece, Direct Drive, Ac-Powered EKX
    Plate, Bone JEY
    Bone Grafting Material, Synthetic LYC
    Scalpel, One-Piece GDX
    Barrier, Synthetic, Intraoral NPK
    Screw, Fixation, Intraosseous DZL
    Screw, Fixation, Bone HWC
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM

    Proprietary Names

    NeoCote NeoTape NeoPlug C-Graft Putty C-Blast Putty Biotex The Cover Citagenix Neomem CevOss The Graft Collagen Exel DISPOSABLE BONE SYRINGES Neomem FlexPlus The Graft Penguin RFA DynaGraft-D Eclipse Putty PreservaRidge DynaBlast Surgistar blades Opentex Eclipse Monoglyc

    Establishment Types

    Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device