BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Asahi Kasei Pharma Corporation, Ohito

    Reg #: 8043889 · FEI: 3003206796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Asahi Kasei Pharma Corporation, Ohito
    Registration Number
    8043889
    FEI Number
    3003206796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    632-1 Mifuku
    City
    Izunokuni City Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K170147

    Owner / Operator

    Firm Name
    Asahi Kasei Pharma Corporation
    Operator Number
    10059378
    Address
    1-1-2 Yurakucho
    City
    Chiyoda-ku
    State
    Tokyo
    Postal Code
    100-0006
    Country
    JP

    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
    Assay, Glycosylated Hemoglobin LCP

    Establishment Types

    Manufacture Medical Device