BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Perfect PFE

    Reg #: 3003446042 · FEI: 3003446042 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    TENSCARE LTD.
    Registration Number
    3003446042
    FEI Number
    3003446042
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK
    City
    EPSOM Surrey
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K191312

    Owner / Operator

    Firm Name
    TENSCARE LTD.
    Operator Number
    9046089
    Address
    PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK
    City
    EPSOM
    State
    Surrey
    Postal Code
    KT19 9BE
    Country
    GB
    Correspondent
    Saskia Eldridge-Hinmers

    US Agent

    Business Name
    QA/RA Consulting Group, Inc.
    Contact Name
    Scott Bednar
    Address
    3335 Tuscarawas Road
    City
    Beaver
    State
    PA
    ZIP
    15009
    Country
    US
    Email
    [email protected]
    Phone
    412 4188066

    Products

    Device Name Product Code
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI

    Proprietary Names

    Perfect PFE Sure+

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device