BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Paste Fillers

    Reg #: 8030343 · FEI: 1000550480 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MANI, INC. (TAKANEZAWA FACILITY)
    Registration Number
    8030343
    FEI Number
    1000550480
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    743, NAKAAKUTSU
    City
    TAKANEZAWA 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
    File, Pulp Canal, Endodontic EKS

    Proprietary Names

    Paste Fillers MANI JIZAI MANI GLIDE FINDERS MANI MICRO FILES TYPE K MANI FLEXILE FILES MANI RT FILES JIZAI GLIDER MANI SEC O-FILES H MANI NRT FILES SILK MANI MEDIUM FLEXILE FILES MANI U-FILES MANI NiTi FILES MANI FLARE FILES MANI MICRO FILES TYPE H MANI K-FILES MANI MEDIUM H-FILES MANI MEDIUM K-FILES MANI SEC O-FILES K MANI MICRO FILES TYPE U MANI SEC O-FILES, H MANI D FINDERS MANI FLARE FILES NiTi MANI SUPER FILES MANI NRT FILES GPR MANI MEDIUM FLARE FILES MANI NiTi FILES R MANI SEC O-FILES, K MANI NRT FILES MANI H-FILES MANI H-FILES NiTi MANI MICRO FILES TYPE F MANI PASTE CARRIERS MANI SEC O-Files

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)