Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1217805

FEI Number

1217805

Entity Name

TOMY International, Inc.

City/State/Country

Canton, MA, US

Establishment Address

45 Shawmut Rd, Canton, MA 02021, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TOMY International, Inc. (Owner Number: 9100882)

Owner / Operator Contact Address

2015 Spring Road, Suite 700, Oak Brook, IL 60523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BABE DIGITAL American Red Cross MULTIPLE DIGITAL THERMOMETER Y6228 Quiet Expressions, Y4612 Sole Expression, Y6053 Quite Expressions Plus Double Nursing Care Disposable Breast Wipes Y4626 Y4947 The First Years Breastflow Memory Rechargeable Breast Pump - Double Y5288 The First Years STAR TEETHER The First Years BOON Passive Silicone Pump ELECTRIC The First Years BATTERY TEETHER The First Years TFY Teething Trainer Cup Digital Thermometer American Red Cross Boon B11193 Medicine Spoon MEDICINE FEEDER Boon B11186 Nasal Aspirator American Red Cross American Red Cross Cool Mist Humidifer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	1992-07-20
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2008-12-22
NXH	Nursing Pad, Cohesive Gel	General Hospital	Class 1	880.5630	2014-02-25
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2013-06-03
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2002-08-23
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2014-07-29
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	1997-04-14
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2002-08-23
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-07-02
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	1992-07-20
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	1992-07-20
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2006-12-13

Official Correspondent

Kenneth Li

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TOMY International, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006852457	TOMY International	Dyersville, IA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1217805. Last updated year: 2026. Please use registration number 1217805 when referencing this establishment in official correspondence.