BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DGI Group LLC

    Reg #: 3014527929 · FEI: 3014527929 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DGI Group LLC
    Registration Number
    3014527929
    FEI Number
    3014527929
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    400 CANDLEWOOD COMMONS
    City
    Howell
    State
    NJ
    ZIP
    07731
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222356

    Owner / Operator

    Firm Name
    DGI GROUP LLC
    Operator Number
    10057329
    Address
    400 Candelwood Commons
    City
    Howell
    State
    NJ
    Postal Code
    07731
    Country
    US
    Correspondent
    Jeremy Josephson

    Products

    Device Name Product Code
    Unit, Cryosurgical, Accessories GEH

    Proprietary Names

    Claritag Advanced Claritag RX

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device