BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    TOMY INTERNATIONAL INC., C/O RC2 (H.K.) LTD.

    Reg #: 3008687634 · FEI: 3008687634 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    TOMY INTERNATIONAL INC., C/O RC2 (H.K.) LTD.
    Registration Number
    3008687634
    FEI Number
    3008687634
    Status
    Active
    Expiry Year
    2026
    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
    K052531

    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
    Ring, Teething, Fluid-Filled KKO
    Pump, Breast, Powered HGX
    Continuous Measurement Thermometer FLL
    Pump, Breast, Non-Powered HGY
    Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
    Dispenser, Liquid Medication KYX
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Syringe, Ent KCP
    Ring, Teething, Non-Fluid Filled MEF
    Toothbrush, Manual EFW
    Pack, Hot Or Cold, Reusable IME

    Proprietary Names

    TOMY, The First Years, LAMAZE/JOHN DEERE RING, TEETHING, FLUID-FILLED Y6228 Quiet Expressions TOMY / ARC Thermometer, electronic, clinical TOMY PUMP, BREAST, NON-POWERED The First Years TOMY HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE) American Red Cross TOMY DISPENSER, LIQUID MEDICATION Sunscreen Applicator TOMY /ARC SYRINGE, ENT TEETHING, NON-FLUID FILLED TFY Teething Trainer Cup TOMY TOOTHBRUSH TOMY PACK, HOT OR COLD

    Establishment Types

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