BEUDAMED
    FDA Registration Active 🇭🇷 Croatia

    Z-ONE (MG455A)

    Reg #: 3016746289 · FEI: 3016746289 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ZAMAR MEDICAL DOO
    Registration Number
    3016746289
    FEI Number
    3016746289
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sv. Martin 6,
    City
    Vrsar Istarska Zupanija
    Country
    HR

    Regulatory Submissions

    510(k) Number
    K242754

    Owner / Operator

    Firm Name
    ZAMAR MEDICAL DOO
    Operator Number
    10084778
    Address
    Sv. Martin 6,
    City
    Vrsar
    State
    Istarska Zupanija
    Postal Code
    52450
    Country
    HR
    Correspondent
    GIANMARCO ZANOTTI

    US Agent

    Business Name
    ZAMAR NORTH AMERICA CORP.
    Contact Name
    Chris Werth
    Address
    9 East Loockerman St. Ste 311
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    913 2206556

    Products

    Device Name Product Code
    Pack, Hot Or Cold, Water Circulating ILO
    Massager, Powered Inflatable Tube IRP

    Proprietary Names

    Z-ONE (MG455A) ZT Cube (ZC3) (MG465A) ZT Clinic (MG675A)

    Establishment Types

    Manufacture Medical Device