BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Kitazato OPU Reduced Needle (model number Type3)

    Reg #: 3015136743 · FEI: 3015136743 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERI-TECH CO.,LTD.
    Registration Number
    3015136743
    FEI Number
    3015136743
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-13-1 HANASAKI
    City
    KAZO-SHI Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K162881

    Owner / Operator

    Firm Name
    Steri-Tech Co.,Ltd.
    Operator Number
    10059220
    Address
    5-13-1 HANASAKI
    City
    KAZO-SHI
    State
    Saitama
    Postal Code
    347-0032
    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
    Needle, Assisted Reproduction MQE

    Proprietary Names

    Kitazato OPU Reduced Needle (model number Type3) Kitazato OPU Two-Stage Reduced Needle (model number Type4) Kitazato OPU Needle with Connection Tube (model number Type2)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)