Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008687634

FEI Number

3008687634

Entity Name

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

City/State/Country

Kowloon Bay, HK

Establishment Address

room 901-906, Tower 1, enterprise square, 9 Sheung Yuet Road,, Kowloon Bay 999077, HK

Establishment Type(s)

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

Owner / Operator

TOMY International Inc. (Owner Number: 10033889)

Owner / Operator Contact Address

Room 901-6, Tower 1, Enterprise Square, 9 Sheung Yuet Road,, Kowloon Bay, HK-NOTA 0, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 American Red Cross Sunscreen Applicator TOMY /ARC SYRINGE, ENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2010-10-15
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2010-10-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2010-10-15
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2010-10-14
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2010-10-14
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2010-10-14
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-11-15
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2010-10-14

Official Correspondent

Kenneth Li

US Agent Details

Kenneth LI Business: Director of Product Integrity Email: kkli@tomy.com Phone: (630) 5737350

Related Public Records

Same Entity

TOMY International Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18

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3004529379	SOLID TOYS IND. LTD.	Boluo County, Huizhou,City Guangdong, CN
3027519000	TREASURE BABY TOYS (DONGGUAN) LIMITED	Dongguan City Guangdong, CN
3010337881	Allied Hill Enterprises, Ltd.	Hong Kong, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008687634. Last updated year: 2026. Please use registration number 3008687634 when referencing this establishment in official correspondence.