BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SupraFuser B Ultrasonic Generator

    Reg #: 3030655570 · FEI: 3030655570 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MEDIWORX.ONE GMBH
    Registration Number
    3030655570
    FEI Number
    3030655570
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Otto-Hahn-Str. 7
    City
    Singen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K171228

    Owner / Operator

    Firm Name
    mediworx.one GmbH
    Operator Number
    10090034
    Address
    Otto-Hahn-Str. 7
    City
    Singen
    State
    Baden-Wurttemberg
    Postal Code
    78224
    Country
    DE
    Correspondent
    Olaf Schaefer

    US Agent

    Business Name
    FDAbasics LLC
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd.
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    715 7750533

    Products

    Device Name Product Code
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Pin, Fixation, Smooth HTY
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT

    Proprietary Names

    SupraFuser B Ultrasonic Generator

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)