BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Bioptimal International Pte. Ltd.

    Reg #: 8043983 · FEI: 3016261803 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    Bioptimal International Pte. Ltd.
    Registration Number
    8043983
    FEI Number
    3016261803
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14 Kaki Bukit View
    City
    SINGAPORE South East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K973477

    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
    Catheter, Embolectomy DXE
    Catheter, Intravascular, Diagnostic DQO
    Transducer, Blood-Pressure, Extravascular DRS
    Catheter, Retention Type, Balloon EZL
    Electrode, Pacemaker, Temporary LDF
    Catheter, Flow Directed DYG
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Probe, Thermodilution KRB

    Proprietary Names

    Bioptimal Embolectomy Catheter Inline Sensor Assembly and Accutrans¿ Disposable Pressure Monitoring System Silicon Foley Catheter Bioport System Bioptimal Bipolar Pacing Catheter Biotrans¿ Reusable Sensor Base Bioptimal Pulmonary Artery Monitoring Catheter Catheter and Accessories Heparin Coated Thermodilution Bioptimal Central Venous Catheter Biotrans¿ Pressure Monitoring Kits and Accessories Thermodilution Catheter Safetywedge¿ Relief Thermodilution Catheter and

    Establishment Types

    Manufacture Medical Device