BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MANI, INC. (HANAOKA FACTORY)

    Reg #: 3004467019 · FEI: 3004467019 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    39
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MANI, INC. (HANAOKA FACTORY)
    Registration Number
    3004467019
    FEI Number
    3004467019
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    151 HANAOKA, OOAZA, TAKANEZAWA
    City
    SHIOYA Tochigi
    Country
    JP

    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
    Knife, Ophthalmic HNN
    File, Pulp Canal, Endodontic EKS

    Proprietary Names

    MANI Ophthalmic Knife Straight MANI TRABECULOTOMY HOOK MANI Ophthalmic Knife Guard Crescent Double Step - Angled 1 mm Slit MPK Golf/Scleral Rslit (Implant) MANI Ophthalmic Knife MVR Paste Fillers MANI GLIDE FINDERS MANI JIZAI MANI H-FILES MANI FLEXILE FILES MANI PASTE CARRIERS JIZAI GLIDER MANI MEDIUM FLEXILE FILES MANI MICRO FILES TYPE H MANI FLARE FILES MANI K-FILES MANI MEDIUM FLARE FILES MANI SEC O-FILES, H MANI RT FILES MANI FLARE FILES NiTi MANI SEC O-FILES, K MANI MICRO FILES TYPE K MANI H-FILES NiTi MANI NiTi FILES MANI MICRO FILES TYPE F MANI SUPER FILES MANI MEDIUM H-FILES MANI MEDIUM K-FILES MANI D FINDERS MANI MICRO FILES TYPE U MANI SEC O-FILES MANI NiTi FILES R MANI U-FILES

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)