BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Omura Kogyo Co., Ltd. Hara Factory

    Reg #: 3016927399 · FEI: 3016927399 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    Omura Kogyo Co., Ltd. Hara Factory
    Registration Number
    3016927399
    FEI Number
    3016927399
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    26-1 Hara
    City
    Numazu Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K162051

    Owner / Operator

    Firm Name
    REPROLIFE Inc.
    Operator Number
    10073837
    Address
    2-5-3-9F Shinjuku
    City
    Shinjuku-ku
    State
    Tokyo
    Postal Code
    160-0022
    Country
    JP
    Correspondent
    Shin Tanaka

    US Agent

    Business Name
    Globizz Corporation
    Contact Name
    Takahiro Haruyama
    Address
    970 W. 190th St. Suite 200
    City
    Torrance
    State
    CA
    ZIP
    90502
    Country
    US
    Email
    [email protected]
    Phone
    310 5383860

    Products

    Device Name Product Code
    Labware, Assisted Reproduction MQK
    Labware, Assisted Reproduction, Exempt PUD

    Proprietary Names

    Tissue Storage: 10 Cryotec Vitri Plate-10 Plates Warm Plate-10 Plates

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)