BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRIMO PASSI

    Reg #: 3034993050 · FEI: 3034993050 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    PRIMO PASSI
    Registration Number
    3034993050
    FEI Number
    3034993050
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    7524 Currency Dr.
    City
    Orlando
    State
    FL
    ZIP
    32809
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131243

    Owner / Operator

    Firm Name
    Primo Passi
    Operator Number
    10092542
    Address
    2637 E. Atlantic Blvd
    City
    Pompano Beach
    State
    FL
    Postal Code
    33062
    Country
    US
    Correspondent
    Yaluan M Giurizatto

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    Pump, Breast, Powered HGX
    Adaptor, Grooming ILW
    Exerciser, Powered BXB

    Proprietary Names

    Primo Passi Ear and Forehead Thermomter Primo Passi Wearable Breast Pump Primo Passi Electric Nail Filer Primo Passi Lactation Massager Primo Passi Portable Dual Charge Electric Breast Pump Primo Passi Double Electric Breast pump

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility