BEUDAMED
    FDA Registration Active 🇨🇳 China

    Bioptimal Embolectomy Catheter

    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
    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
    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
    Catheter, Embolectomy DXE

    Proprietary Names

    Bioptimal Embolectomy Catheter

    Establishment Types

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