BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    MANI Sutures, Ophthalmic Sutures ( with Needle)

    Reg #: 3014276972 · FEI: 3014276972 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Mani Hanoi Co. Ltd Pho Yen 2 Factory
    Registration Number
    3014276972
    FEI Number
    3014276972
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot CN5, Diem Thuy Industrial Zone - Area A, Hong Tien Ward
    City
    Pho Yen City, Thai Nguyen Province
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K053637

    Owner / Operator

    Firm Name
    MANI, INC. (HEAD OFFICE)
    Operator Number
    8030343
    Address
    8-3 KIYOHARA INDUSTRIAL PARK, --
    City
    UTSUNOMIYA, TOCHIGI
    State
    JP-NOTA
    Postal Code
    321-3231
    Country
    JP
    Correspondent
    Toshiharu Kamei

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyamide GAR

    Proprietary Names

    MANI Sutures, Ophthalmic Sutures ( with Needle) MANI Sutures Nylon

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)