Data / Medical devices / Hong Kong / TOMY (Hong Kong) Limited
TOMY (Hong Kong) Limited: FDA-registered device maker in Kowloon, Hong Kong, Hong Kong, 3 510(k) clearances
TOMY (Hong Kong) Limited is registered with the FDA (registration 3008687634) in Kowloon, Hong Kong, Hong Kong. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 9, 2008. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008687634
- Address
- 3101-2 & 12B, 31/F, Exchange Tower 33 Wang Chiu Road, Kowloon Bay, Kowloon, Hong Kong, Hong Kong, 999077
- Owner or operator
- TOMY International Inc. (10033889)
- Roles
- Exporter to the US
- First device listed
- October 14, 2010
- Registered through
- 2027
- Brand names listed
- American Red Cross, Sunscreen Applicator, TEETHING, NON-FLUID FILLED, TFY Teething Trainer Cup, TOMY / ARC Thermometer, electronic, clinical, TOMY /ARC SYRINGE, ENT, TOMY DISPENSER, LIQUID MEDICATION, TOMY HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Exporter to the US | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Exporter to the US | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Exporter to the US | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Exporter to the US | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Exporter to the US | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Exporter to the US | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Exporter to the US | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 9, 2008 | K082802 | MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B | HGX | Substantially Equivalent | Learning Curve Brands Inc. the First Years | accessdata.fda.gov |
| December 14, 2005 | K052531 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | KKO | Substantially Equivalent | Fu Hong Industries , Ltd. | accessdata.fda.gov |
| May 23, 1985 | K851146 | DIGITAL THERMOMETER | FLL | Substantially Equivalent | Micro Idea Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Syringe, Ent
- All makers of Pump, Breast, Powered
- All makers of Dispenser, Liquid Medication
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Pack, Hot Or Cold, Reusable
Updated October 9, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.