BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Everion+ System

    Reg #: 3015280546 · FEI: 3015280546 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    BIOFOURMIS SINGAPORE PTE LTD
    Registration Number
    3015280546
    FEI Number
    3015280546
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Venture Drive, #07-16 Vision Exchange
    City
    Singapore South West
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K213863

    Owner / Operator

    Firm Name
    BIOFOURMIS SINGAPORE PTE LTD
    Operator Number
    10060026
    Address
    2 VENTURE DRIVE, VISION EXCHANGE, #23-01
    City
    SINGAPORE
    State
    South West
    Postal Code
    608526
    Country
    SG

    US Agent

    Business Name
    Biofourmis
    Contact Name
    David Koretz
    Address
    117 Kendrick St, Suite 300
    City
    Needham
    State
    MA
    ZIP
    02494
    Country
    US
    Email
    [email protected]
    Phone
    617 3345441

    Products

    Device Name Product Code
    Monitor, Breathing Frequency BZQ
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    Everion+ System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198