BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    OvuSense

    Reg #: 3009307663 · FEI: 3009307663 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Trelleborg Sealing Solutions Weobley Limited
    Registration Number
    3009307663
    FEI Number
    3009307663
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kington Road Industrial Estate
    City
    Weobley Herefordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K122337

    Owner / Operator

    Firm Name
    Trelleborg Sealing Solutions Plymouth LLC
    Operator Number
    9102441
    Address
    1100 XENIUM LANE NORTH, --
    City
    Minneapolis
    State
    MN
    Postal Code
    55441
    Country
    US

    US Agent

    Business Name
    Trelleborg Sealing Solutions Plymouth LLC
    Contact Name
    Heaven Clausen
    Address
    1100 Xenium Ln N
    City
    Minneapolis
    State
    MN
    ZIP
    55441
    Country
    US
    Email
    [email protected]
    Phone
    952 9271441

    Products

    Device Name Product Code
    Device, Fertility Diagnostic, Proceptive LHD

    Proprietary Names

    OvuSense OvuSense Fertility Monitor System. M026 OvuCore Vaginal Sensor, M426 OvuFirst Skin Worn Sensor and M032 OvuSense App.

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)