BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    twoplus Applicator

    Reg #: 3017438142 · FEI: 3017438142 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    HANNAH LIFE TECHNOLOGIES PTE. LTD.
    Registration Number
    3017438142
    FEI Number
    3017438142
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Sims Close, #03-04 Gemini @ Sims
    City
    Singapore North East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K232579

    Owner / Operator

    Firm Name
    Hannah Life Technologies Pte. Ltd.
    Operator Number
    10085111
    Address
    2 Sims Close, #03-04 Gemini @ Sims
    City
    Singapore
    State
    North East
    Postal Code
    387298
    Country
    SG
    Correspondent
    Prusothman M Sina Raja

    US Agent

    Business Name
    Matrix Medical Consulting, Inc.
    Contact Name
    Alan Donald
    Address
    8880 Rio San Diego Drive, Suite 800
    City
    San Diego
    State
    CA
    ZIP
    92108
    Country
    US
    Email
    [email protected]
    Phone
    619 2085624

    Products

    Device Name Product Code
    At Home Intravaginal Insemination System QYZ

    Proprietary Names

    twoplus Applicator

    Establishment Types

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