BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    BLU TOTALE

    Reg #: 3007554929 · FEI: 3007554929 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PREMIER DEAD SEA COSMETIC LABORATORIES LTD
    Registration Number
    3007554929
    FEI Number
    3007554929
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    21 Hashaked St. Shoham Industry Park
    City
    Shoham Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K232656

    Owner / Operator

    Firm Name
    Premier Dead Sea Cosmetic Laboratories Ltd
    Operator Number
    10058378
    Address
    21 Hashaked St. Shoham Industry Park
    City
    Shoham
    State
    Central
    Postal Code
    6085001
    Country
    IL
    Correspondent
    Yaneev Yuval

    US Agent

    Business Name
    PREMIER NORTH AMERICA, INC
    Contact Name
    Ellis Tamari
    Address
    1321 NW 65TH PL STE 3
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33309
    Country
    US
    Email
    [email protected]
    Phone
    404 4928133 ext. 116

    Products

    Device Name Product Code
    Over-The-Counter Powered Light Based Laser For Acne OLP

    Proprietary Names

    BLU TOTALE

    Establishment Types

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