BEUDAMED
    FDA Registration Active 🇨🇳 China

    Biotrans¿ Pressure Monitoring Kits

    Reg #: 3008496528 · FEI: 3008496528 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOXIN MEDICAL CO., LTD
    Registration Number
    3008496528
    FEI Number
    3008496528
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 288-7 Shanhai Road, Torch Hi-tech Science Park
    City
    Wei hai Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K981747

    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
    Correspondent
    John Yong Ji - Min

    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
    Transducer, Blood-Pressure, Extravascular DRS

    Proprietary Names

    Biotrans¿ Pressure Monitoring Kits

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)