Data / Medical devices / China / Dongguan Qing Xi Essentia Industries Ltd
Dongguan Qing Xi Essentia Industries Ltd: FDA-registered device maker in Dongguan Guangdong, China, 3 510(k) clearances
Dongguan Qing Xi Essentia Industries Ltd is registered with the FDA (registration 3010626066) in Dongguan Guangdong, China. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 24, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010626066
- Address
- Building 2, No. 94, Yanhe East 1st Road, Dongkeng Town Dongguan, Guangdong, China, Dongguan Guangdong, China, 523456
- Owner or operator
- ELUNG INDUSTRIAL CO.LTD. (9052953)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- February 1, 2003
- Registered through
- 2026
- Brand names listed
- APPARATUS, Gel Soothers, Ice Gel Soothers, Ice Gel Teethers, LAMBS FEEDING, LUV N'CARE, MEDICINE SYRINGE, NIPPLE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Manufacturer | accessdata.fda.gov |
| Nipple, Lambs Feeding | FNN | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Manufacturer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | 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 24, 2010 | K100385 | NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP | HGX | Substantially Equivalent | Luv N' Care, Ltd. | accessdata.fda.gov |
| 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 Nipple, Lambs Feeding
- All makers of Ring, Teething, Non-Fluid Filled
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Pump, Breast, Powered
- All makers of Massager, Therapeutic, Electric
- All makers of Massager, Therapeutic, Manual
Updated March 24, 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.