BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    One Touch Delica Plus Lancing Device

    Reg #: 3006602625 · FEI: 3006602625 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PRONICS VIETNAM CO.,LTD
    Registration Number
    3006602625
    FEI Number
    3006602625
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot M22a-24, Road 12
    City
    Ho Chi Minh
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K221546

    Owner / Operator

    Firm Name
    PRONICS VIETNAM CO.,LTD
    Operator Number
    10059785
    Address
    Lot M22a-24, Road 12
    City
    Ho Chi Minh
    State
    VN-SG
    Postal Code
    70000
    Country
    VN
    Correspondent
    HIRANO YASUTOSHI

    US Agent

    Business Name
    APS America LLC
    Contact Name
    Greg Lamps
    Address
    1850 Parkway Place, Suite 410
    City
    Marietta
    State
    GA
    ZIP
    30067
    Country
    US
    Email
    [email protected]
    Phone
    678 6015370

    Products

    Device Name Product Code
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    One Touch Delica Plus Lancing Device

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)