BEUDAMED
    FDA Registration Active 🇷🇴 Romania

    FLEXITIME XTREME 2

    Reg #: 3011203516 · FEI: 3011203516 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Kulzer SRL
    Registration Number
    3011203516
    FEI Number
    3011203516
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Claderia C3, Dietrich Honold 1
    City
    Sacalaz-Judet Timis
    Country
    RO

    Regulatory Submissions

    510(k) Number
    K101617

    Owner / Operator

    Firm Name
    KULZER, LLC
    Operator Number
    9056636
    Address
    4315 S. Lafayette Blvd.
    City
    South Bend
    State
    IN
    Postal Code
    46614
    Country
    US
    Correspondent
    David A Vincent

    US Agent

    Business Name
    Kulzer, LLC
    Contact Name
    David Vincent
    Address
    4315 S Lafayette Blvd
    City
    South Bend
    State
    IN
    ZIP
    46614
    Country
    US
    Email
    [email protected]
    Phone
    574 2995421

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    FLEXITIME XTREME 2

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)