BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PSM Medical GmbH

    Reg #: 3008323540 · FEI: 3008323540 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    PSM Medical GmbH
    Registration Number
    3008323540
    FEI Number
    3008323540
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gewerbestr. 10
    City
    Gunningen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K110392

    Owner / Operator

    Firm Name
    PSM Medical GmbH
    Operator Number
    10034286
    Address
    Gewerbestr. 10
    City
    Gunningen
    State
    Baden-Wurttemberg
    Postal Code
    78594
    Country
    DE
    Correspondent
    Marcel Schmid

    US Agent

    Business Name
    PSM North America, Inc
    Contact Name
    Terry Pracht
    Address
    80900 Weiskopf
    City
    La Quinta
    State
    CA
    ZIP
    92253
    Country
    US
    Email
    [email protected]
    Phone
    800 7331622

    Products

    Device Name Product Code
    Handle, Instrument, Dental EJB
    Spring, Orthodontic ECO
    Bit, Drill HTW
    Screwdriver HXX
    Retainer, Screw Expansion, Orthodontic DYJ
    Tray, Surgical LRP
    Implant, Endosseous, Orthodontic OAT
    Tube, Orthodontic DZD
    Bur, Dental EJL
    Bracket, Metal, Orthodontic EJF
    Forceps HTD
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Econoline Brackets Triamond Brackets Flair Brackets Crown Brackets

    Establishment Types

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