BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Bioptimal Bipolar Pacing Catheter

    Reg #: 8043983 · FEI: 3016261803 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Bioptimal International Pte. Ltd.
    Registration Number
    8043983
    FEI Number
    3016261803
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14 Kaki Bukit View
    City
    SINGAPORE South East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K242863

    Owner / Operator

    Firm Name
    BIOPTIMAL INTERNATIONAL PTE LTD
    Operator Number
    9004883
    Address
    14 Kaki Bukit View
    City
    Singapore
    State
    South East
    Postal Code
    415950
    Country
    SG

    US Agent

    Business Name
    BIOMEDICAL SALES INTERNATIONAL, INC.
    Contact Name
    Dennis Bassett
    Address
    457 W Virginia Ave
    City
    Punta Gorda
    State
    FL
    ZIP
    33950
    Country
    US
    Email
    [email protected]
    Phone
    513 2586555

    Products

    Device Name Product Code
    Electrode, Pacemaker, Temporary LDF

    Proprietary Names

    Bioptimal Bipolar Pacing Catheter

    Establishment Types

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