BEUDAMED
    FDA Registration Active 🇺🇸 United States

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    Reg #: 3017230582 · FEI: 3017230582 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PELVITAL USA, INC.
    Registration Number
    3017230582
    FEI Number
    3017230582
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    860 Blue Gentian Rd, Suite 200
    City
    Eagan
    State
    MN
    ZIP
    55121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200409

    Owner / Operator

    Firm Name
    Pelvital USA, Inc.
    Operator Number
    10077256
    Address
    860 Blue Gentian Rd, Suite 200
    City
    Eagan
    State
    MN
    Postal Code
    55121
    Country
    US
    Correspondent
    Lydia Zeller

    Products

    Device Name Product Code
    Perineometer HIR

    Proprietary Names

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    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198