BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OneTouch Delica Safety

    Reg #: 3002807408 · FEI: 3002807408 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KOGA ISOTOPE LTD.
    Registration Number
    3002807408
    FEI Number
    3002807408
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    53-6 Jinbo,Koka-cho
    City
    Koka-shi Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K222084

    Owner / Operator

    Firm Name
    KOGA ISOTOPE LTD.
    Operator Number
    10025197
    Address
    53-6 Jinbo,Koka-cho
    City
    Koka-shi
    State
    Shiga
    Postal Code
    520-3404
    Country
    JP

    US Agent

    Business Name
    Center for Regulatory Services, Inc.
    Contact Name
    Kristi Smedley
    Address
    1536 Canoe House Rd
    City
    Jamaica
    State
    VA
    ZIP
    23079
    Country
    US
    Email
    [email protected]
    Phone
    703 7867674

    Products

    Device Name Product Code
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Proprietary Names

    OneTouch Delica Safety Capiject Safety Lancet Assure Lance Assure Lance Plus Heel Lancet Newborn HemoCue Safety Lancet

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)