BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    viO HealthTech Limited

    Reg #: 3006799946 · FEI: 3006799946 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    viO HealthTech Limited
    Registration Number
    3006799946
    FEI Number
    3006799946
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 211, Basepoint Business Centre, 377-399 London Road
    City
    Camberley Surrey
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K122337

    Owner / Operator

    Firm Name
    viO HealthTech Limited
    Operator Number
    10023236
    Address
    Unit 211, Basepoint Business Centre, 377-399 London Road
    City
    Camberley
    State
    Surrey
    Postal Code
    GU15 3HL
    Country
    GB
    Correspondent
    Robert Milnes

    US Agent

    Business Name
    viO HealthTech Inc.
    Contact Name
    Craig Citron
    Address
    79 Cypress Rd
    City
    Old Saybrook
    State
    CT
    ZIP
    06475
    Country
    US
    Email
    [email protected]
    Phone
    203 6400268

    Products

    Device Name Product Code
    Device, Fertility Diagnostic, Proceptive LHD

    Proprietary Names

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility