BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Y6228 Quiet Expressions

    Reg #: 3008687634 · FEI: 3008687634 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TOMY INTERNATIONAL INC., C/O RC2 (H.K.) LTD.
    Registration Number
    3008687634
    FEI Number
    3008687634
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    room 901-906, Tower 1, enterprise square, 9 Sheung Yuet Road,
    City
    Kowloon Bay
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K082802

    Owner / Operator

    Firm Name
    TOMY International Inc.
    Operator Number
    10033889
    Address
    Room 901-6, Tower 1, Enterprise Square, 9 Sheung Yuet Road,
    City
    Kowloon Bay
    State
    HK-NOTA
    Postal Code
    0
    Country
    HK
    Correspondent
    Kenneth Li

    US Agent

    Business Name
    Director of Product Integrity
    Contact Name
    Kenneth LI
    Address
    45 SHAWMUT RD
    City
    CANTON
    State
    MA
    ZIP
    02021
    Country
    US
    Email
    [email protected]
    Phone
    630 5737350

    Products

    Device Name Product Code
    Pump, Breast, Powered HGX

    Proprietary Names

    Y6228 Quiet Expressions

    Establishment Types

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