FDA Registration
Active
🇺🇸 United States
TOMY International, Inc.
Reg #: 1217805
·
FEI: 1217805
·
Expires 2026
Products
15
Proprietary Names
26
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- TOMY International, Inc.
- Registration Number
- 1217805
- FEI Number
- 1217805
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 45 Shawmut Rd
- City
- Canton
- State
- MA
- ZIP
- 02021
- Country
- US
Regulatory Submissions
- 510(k) Number
- K851146
Owner / Operator
- Firm Name
- TOMY International, Inc.
- Operator Number
- 9100882
- Address
- 2015 Spring Road, Suite 700
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Kenneth Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 1992-07-20 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2008-12-22 |
| Nursing Pad, Cohesive Gel | NXH | Class 1 | General Hospital | No | 2014-02-25 |
| Ring, Teething, Fluid-Filled | KKO | Class 2 | Dental | No | 2002-08-23 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2014-07-29 |
| Ring, Teething, Non-Fluid Filled | MEF | Class 1 | Dental | No | 2002-08-23 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-02 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 1992-07-20 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 1992-07-20 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2006-12-13 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2021-12-02 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 1992-07-20 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2024-11-15 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 1992-07-20 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2009-05-28 |
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
BATTERY
TEETHER
TFY Teething Trainer Cup
Digital Thermometer
Boon B11193 Medicine Spoon
MEDICINE FEEDER
Boon B11186 Nasal Aspirator
American Red Cross Cool Mist Humidifer
American Red Cross Nasal Aspirator
COLD PACK, ICE WRAP
Sunscreen Applicator
Boon B11189 Toothbrush
GROOMING SET
MULTIPLE MY OWN TOOTHBRUSH
Colic / Baby Massage Pad
Y6209 The First Years My Expressions Manual Breast Pump
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility