BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ASTEC CO., Ltd.

    Reg #: 3007459332 · FEI: 3007459332 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ASTEC CO., Ltd.
    Registration Number
    3007459332
    FEI Number
    3007459332
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4-6-15 Minamizato, Shime
    City
    Kasuya Fukuoka
    Country
    JP

    Owner / Operator

    Firm Name
    ASTEC Co., Ltd.
    Operator Number
    10060470
    Address
    4-6-15 Minamizato, Shime
    City
    Kasuya
    State
    Fukuoka
    Postal Code
    8112207
    Country
    JP

    US Agent

    Business Name
    Astec Bio USA, Inc.
    Contact Name
    Donald J Luongo
    Address
    10 Keith Way Suite 3
    City
    Hingham
    State
    MA
    ZIP
    02043
    Country
    US
    Email
    [email protected]
    Phone
    781 7490734

    Products

    Device Name Product Code
    Accessory, Assisted Reproduction, Exempt PUB
    Labware, Assisted Reproduction, Exempt PUD

    Proprietary Names

    EC10-120MD EC6S-120MD Embryo Grid ASTEC IVF 35mm Culture Dish ASTEC IVF Center Well Dish ASTEC IVF ICSI Dish ASTEC IVF 4Well Dish, Model Number AID-4W ASTEC IVF 4Well Dish, Model Number AID-4WH ASTEC IVF 60mm Culture Dish

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility