BEUDAMED
    FDA Registration Active 🇨🇳 China

    Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

    Reg #: 3023235140 · FEI: 3023235140 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    WUHAN HUCHUANG UNION TECHNOLOGY CO., LTD.
    Registration Number
    3023235140
    FEI Number
    3023235140
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building10, No.818 Gaoxin Avenue
    City
    Wuhan Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232493

    Owner / Operator

    Firm Name
    Wuhan Huchuang Union Technology Co., Ltd.
    Operator Number
    10084962
    Address
    Building10, No.818 Gaoxin Avenue
    City
    Wuhan
    State
    Hubei
    Postal Code
    430206
    Country
    CN
    Correspondent
    Yuanyuan Zhan

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Microscope And Microscope Accessories, Reproduction, Assisted MTX
    Labware, Assisted Reproduction MQK
    Accessory, Assisted Reproduction MQG

    Proprietary Names

    Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device