BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FULWELL LLC

    Reg #: 3010131466 · FEI: 3010131466 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    FULWELL LLC
    Registration Number
    3010131466
    FEI Number
    3010131466
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3411 NW 48 STREET
    City
    Miami
    State
    FL
    ZIP
    33142
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162034

    Owner / Operator

    Firm Name
    Fulwell LLC
    Operator Number
    10043857
    Address
    3411 NW 48 STREET
    City
    Miami
    State
    FL
    Postal Code
    33142
    Country
    US
    Correspondent
    Xi Chen

    Products

    Device Name Product Code
    Forceps, Biopsy, Non-Electric FCL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Electrode, Electrocardiograph DRX

    Proprietary Names

    FORCEPS, BIOPSY, NON-ELECTRIC Electrosurgical, cutting & coagulation & accessories Face Mask Within the Scope of the Face Mask and Barrier Face Covering Enforcement Policy or Face Mask Umbrella EUA Electrode, electrocardiograph

    Establishment Types

    Repack or Relabel Medical Device