BEUDAMED
    FDA Registration Active 🇷🇴 Romania

    Flexitime Unlimited

    Reg #: 3011203516 · FEI: 3011203516 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    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
    K000629

    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 Unlimited Flexitime Easy Putty Flexitime Monophase Flexitime Correct Flow Flexitime Heavy Tray

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)