BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Heraeus Medical GmbH

    Reg #: 3006406161 · FEI: 3006406161 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    Heraeus Medical GmbH
    Registration Number
    3006406161
    FEI Number
    3006406161
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PHILIPP-REIS-STRASSE 8/13
    City
    WEHRHEIM Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K142157

    Owner / Operator

    Firm Name
    Heraeus Medical GmbH
    Operator Number
    10048423
    Address
    Philipp-Reis-Str. 8/13
    City
    Wehrheim
    State
    Hesse
    Postal Code
    61273
    Country
    DE
    Correspondent
    Benjamin Hagedorn

    US Agent

    Business Name
    Heraeus Medical LLC
    Contact Name
    Devin Childers
    Address
    Township Line Road 770, Suite 300,
    City
    Yardley
    State
    PA
    ZIP
    19067
    Country
    US
    Email
    [email protected]
    Phone
    215 5944927 ext. 2

    Products

    Device Name Product Code
    Dispenser, Cement KIH
    Bone Cement, Antibiotic MBB
    Mixer, Cement, For Clinical Use JDZ
    Bone Cement LOD
    Cement, Bone, Vertebroplasty NDN
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Template HWT
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Evacuator, Vapor, Cement Monomer JDY

    Proprietary Names

    PALACOS® R+G pro PALACOS R pro PALACOS MV Palacos LV® + G PALAMIX Cement Gun PALAMIX Nozzle Slim PALAMIX Nozzle Medium pro nozzle medium pro nozzle short with knee pressuriser PALAMIX UNO PALAMIX DUO PALACOS® fast R+G OSTEOPAL V PALACOS® LV Osteopal® COPAL® exchange G Trial Sets COPAL® knee mould Trial S US COPAL® knee mould Trial L US COPAL® knee mould Trial M US Palamed® PALACOS® MV Osteopal® V PALACOS® R+G Palacos G PALACOS® R pro PALACOS® MV+G pro OSTEOPAL® plus COPAL® exchange G PALACOS® MV pro Palamed® G PALACOS® MV+G PALACOS® R Palacos® R COPAL exchange G hip spacer PALAMIX vacuum pump

    Establishment Types

    Manufacture Medical Device