BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Sonopsy Needle

    Reg #: 9611481 · FEI: 3002807220 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HAKKO CO., LTD.
    Registration Number
    9611481
    FEI Number
    3002807220
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1490 O-aza Isobe
    City
    CHIKUMA-SHI Nagano
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K013109

    Owner / Operator

    Firm Name
    HAKKO CO., LTD.
    Operator Number
    8030409
    Address
    Hongo 3 chome, 42-6, Nankodo building 6F
    City
    Bunkyo-ku
    State
    Tokyo
    Postal Code
    1130033
    Country
    JP

    US Agent

    Business Name
    Havel's Inc.
    Contact Name
    Shelly Ast
    Address
    3726 Lonsdale St.
    City
    Cincinnati
    State
    OH
    ZIP
    45227
    Country
    US
    Email
    [email protected]
    Phone
    513 5271273 ext. 18

    Products

    Device Name Product Code
    Biopsy Needle FCG

    Proprietary Names

    Sonopsy Needle

    Establishment Types

    Manufacture Medical Device