Data / Medical devices / China / Shantou Chaonan Liangying Hegao Plastic Toy Factory
Shantou Chaonan Liangying Hegao Plastic Toy Factory: FDA-registered device maker in SHANTOU Guangdong, China, 2 510(k) clearances
Shantou Chaonan Liangying Hegao Plastic Toy Factory is registered with the FDA (registration 3008191511) in SHANTOU Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 1, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008191511
- Address
- Hegao Village, Liangying Town, Chaonan District, Shantou, Guangdong Province, SHANTOU Guangdong, China, 515141
- Owner or operator
- ELUNG INDUSTRIAL CO.LTD. (9052953)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 1, 2006
- Registered through
- 2026
- Brand names listed
- APPARATUS, Gel Soothers, Ice Gel Soothers, Ice Gel Teethers, LUV N'CARE, NON-FLUID FILLED, NONPOWERE, NUBY and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 1, 2010 | K092494 | GEL FILLED GUM SOOTHER | KKO | Substantially Equivalent | Luv N' Care, Ltd. | accessdata.fda.gov |
| June 16, 1998 | K981202 | WATER FILLED GUM SOOTHER | KKO | Substantially Equivalent | Corium Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Manual
- All makers of Ring, Teething, Fluid-Filled
- All makers of Ring, Teething, Non-Fluid Filled
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Updated March 1, 2010. 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.