BEUDAMED
    FDA Registration Active 🇨🇳 China

    KeySplint Soft

    Reg #: 3015674635 · FEI: 3015674635 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GUANGZHOU HEYGEARS IMC.INC
    Registration Number
    3015674635
    FEI Number
    3015674635
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Block B2, 501, 601, Enterprise Accelerator, Kaifa District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K183598

    Owner / Operator

    Firm Name
    GUANGZHOU HEYGEARS IMC.INC
    Operator Number
    10061379
    Address
    BLOCK B2,501,601,ENTERPRISE ACCELERATOR,KAIFA DISTRICT
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510700
    Country
    CN
    Correspondent
    Peiyan Gui

    Products

    Device Name Product Code
    Positioner, Tooth, Preformed KMY
    Mouthguard, Prescription MQC

    Proprietary Names

    KeySplint Soft

    Establishment Types

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