BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PC3-SCSA-3

    Reg #: 3017865161 · FEI: 3017865161 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PEMAX KUNSTSTOFF GMBH
    Registration Number
    3017865161
    FEI Number
    3017865161
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Curiestr. 2
    City
    Stuttgart Baden-Wurttemberg
    Country
    DE

    Owner / Operator

    Firm Name
    Pemax Kunststoff GmbH
    Operator Number
    10079845
    Address
    Curiestr. 2
    City
    Stuttgart
    State
    Baden-Wurttemberg
    Postal Code
    70563
    Country
    DE
    Correspondent
    Ulrich Bahr

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Drape, Surgical, Exempt PUI

    Proprietary Names

    PC3-SCSA-3 Robotic scope sterile drape No. 12364 PC3-VB10-3 6 clip Drape VB10-SC Smart Control Drape Robotic scope sterile drape No. 13928 VB10-RC Remote Control Unit Drap Set PC2-SD-3 HMD cover sterile No. 12364

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198