BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Z-MEDICAL GMBH & CO. KG

    Reg #: 3009110133 · FEI: 3009110133 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    0
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    Z-MEDICAL GMBH & CO. KG
    Registration Number
    3009110133
    FEI Number
    3009110133
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gansacker 38
    City
    Tuttlingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K143200

    Owner / Operator

    Firm Name
    Z-MEDICAL GMBH & CO. KG
    Operator Number
    10036391
    Address
    Gansacker 38
    City
    Tuttlingen
    State
    Baden-Wurttemberg
    Postal Code
    78532
    Country
    DE
    Correspondent
    Zbigniew Combrowski

    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
    Screwdriver HXX
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Screw, Fixation, Bone HWC
    Staple, Fixation, Bone JDR
    Pin, Fixation, Smooth HTY
    Orthopedic Manual Surgical Instrument LXH
    Tray, Surgical, Instrument FSM
    Instrument, Manual, Surgical, General Use MDM
    Tray, Surgical LRP
    Burr, Orthopedic HTT
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Instrument, Microsurgical GZX

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device