BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Merz North America, Inc.

    Reg #: 3013840437 · FEI: 3013840437 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    14
    Establishment Types
    4
    Classifications
    15

    Registration Details

    Registration Name
    Merz North America, Inc.
    Registration Number
    3013840437
    FEI Number
    3013840437
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    13900 W. Grandview Parkway
    City
    Sturtevant
    State
    WI
    ZIP
    53177
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150505
    PMA Number
    P050037

    Owner / Operator

    Firm Name
    Merz North America, Inc.
    Operator Number
    9043404
    Address
    6501 Six Forks Road
    City
    Raleigh
    State
    NC
    Postal Code
    27615
    Country
    US
    Correspondent
    Bonnie Safyurtlu

    Products

    Device Name Product Code
    Powered Surgical Instrument For Improvement In The Appearance Of Cellulite OUP
    Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption OHV
    Cannula, Surgical, General & Plastic Surgery GEA
    Transparent Patch For Use In Treatment Of Tattoos PKO
    Implant, Dermal, For Aesthetic Use LMH
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Single Use Instrument Tray OJV
    Implant, Dermal, For Aesthetic Use In The Hands PKY
    System, Vocal Cord Medialization MIX
    Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
    Kit, Surgical Instrument, Disposable KDD
    Agent, Bulking, Injectable For Gastro-Urology Use LNM
    Instrument, Ent Manual Surgical LRC
    Needle, Gastro-Urology FHR
    Needle, Aspiration And Injection, Disposable GAA

    Proprietary Names

    CSH Cannula; STERiGLIDE Describe Radiesse Injectable Implant Ulthera System Accessory Kit Radiesse® (+) Belotero Balance (+) Lidocaine Dermal Filler Belotero Balance Dermal Filler Prolaryn Gel Injectable Implant Prolaryn Plus Injectable Implant Cellfina System Prep Pack - CP1 Coaptite Injectable Implant Belotero Volume (+) Lidocaine Rigid Injection Needle

    Establishment Types

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