BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Bea Treatment Kit

    Reg #: 3038597712 · FEI: 3038597712 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    STEPONE FERTILITY LTD
    Registration Number
    3038597712
    FEI Number
    3038597712
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    WeWork 123 Buckingham Palace Rd
    City
    London Westminster
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K242031

    Owner / Operator

    Firm Name
    StepOne Fertility Ltd
    Operator Number
    10093574
    Address
    WeWork 123 Buckingham Palace Rd
    City
    London
    State
    London, City of
    Postal Code
    SW1W 9SH
    Country
    GB
    Correspondent
    Tom Littleford

    US Agent

    Business Name
    StepOne Fertility Inc
    Contact Name
    Jessica Eggert
    Address
    169 Madison Ave
    City
    New York
    State
    NY
    ZIP
    10016
    Country
    US
    Email
    [email protected]
    Phone
    978 7319965

    Products

    Device Name Product Code
    Container, Specimen, Sterile FMH
    Cap, Cervical HDR
    Kit, Conception-Assist, Home Use OBB

    Proprietary Names

    Bea Treatment Kit Bea Applicator

    Establishment Types

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