BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    ACIST Kodama® Intravascular Ultrasound Catheter

    Reg #: 3024711423 · FEI: 3024711423 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERI - CARE CO.,LTD
    Registration Number
    3024711423
    FEI Number
    3024711423
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    63B Calmette street, Nguyen Thai Binh ward, District 1, 08 Dao Tri street, Phu Thuan ward, District 7
    City
    Ho Chi Minh
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K193183

    Owner / Operator

    Firm Name
    STERI - CARE CO.,LTD
    Operator Number
    10085847
    Address
    63B Calmette street, Nguyen Thai Binh ward, District 1, 08 Dao Tri street, Phu Thuan ward, District 7
    City
    Ho Chi Minh
    State
    VN-SG
    Postal Code
    700000
    Country
    VN
    Correspondent
    Tien Ky

    Products

    Device Name Product Code
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    ACIST Kodama® Intravascular Ultrasound Catheter

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)