BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Potenza

    Reg #: 3033715699 · FEI: 3033715699 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    JEISYS MEDICAL NORTH AMERICA INC
    Registration Number
    3033715699
    FEI Number
    3033715699
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    70 Blanchard Rd Ste 303
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201685

    Owner / Operator

    Firm Name
    JEISYS MEDICAL NORTH AMERICA INC
    Operator Number
    10091463
    Address
    70 Blanchard Road, Suite 303
    City
    Burlington
    State
    MA
    Postal Code
    01803
    Country
    US

    Products

    Device Name Product Code
    Skin Resurfacing Rf Applicator OUH
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Potenza

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198