FDA Registration
Active
🇺🇸 United States
TOMY International
Reg #: 3006852457
·
FEI: 3006852457
·
Expires 2026
Products
8
Proprietary Names
11
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- TOMY International
- Registration Number
- 3006852457
- FEI Number
- 3006852457
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2021 9TH ST. S.E.
- City
- Dyersville
- State
- IA
- ZIP
- 52040
- Country
- US
Regulatory Submissions
- 510(k) Number
- K851146
Owner / Operator
- Firm Name
- TOMY International, Inc.
- Operator Number
- 9086544
- Address
- 2021 9th Street S.E.
- City
- Dyersville
- State
- IA
- Postal Code
- 52040
- Country
- US
- Correspondent
- Kenneth Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2022-12-07 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2022-12-07 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2015-07-30 |
| Ring, Teething, Fluid-Filled | KKO | Class 2 | Dental | No | 2022-12-07 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2018-06-04 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2024-11-15 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2022-12-07 |
| Ring, Teething, Non-Fluid Filled | MEF | Class 1 | Dental | No | 2019-11-12 |
Proprietary Names
Manual Toothbrush
Dispenser, Liquid Medication
Multi-Use Digital Thermometer
Liquid Filled Teether
Y7797 ARC BEAR ICE WRAP
Y7789 ARC Ice Pack
P17498 Gel Pack
Sunscreen Applicator
Quiet Expressions Breast Pump
TEETHER
The First Years Teether, TFY Teething Trainer Cup
Establishment Types
Complaint File Establishment per 21 CFR 820.198