Dongguan Qing Xi Essentia Industries Ltd
Registered establishment in Dongguan, Guangdong, China. 8 device types.
Dongguan Qing Xi Essentia Industries Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Nipple, Lambs Feeding, Pump, Breast, Powered and 6 other device types. Its earliest product listing with the FDA dates from 2003.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010626066 |
| FEI number | 3010626066 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | Building 2, No. 94, Yanhe East 1st Road, Dongkeng Town |
| Postal code | 523456 |
| Country | China |
Group
Dongguan Qing Xi Essentia Industries Ltd is one of 3 plants registered under ELUNG INDUSTRIAL CO.LTD..
| Plant | City | Device types |
|---|---|---|
| Elung Industrial Co., Ltd. | T.S.T.,Kowloon | 14 |
| Shantou Chaonan Liangying Hegao Plastic TOY Factory | Shantou | 4 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Single Patient USE, Apparatus, Portable, Nonpowere | 2006 | 58 |
| Massager, Therapeutic, Electric | Class 1 | 2025 | 437 | |
| Massager, Therapeutic, Manual | Class 1 | Perineal Massager & Pelvic Wand | 2025 | 113 |
| Nipple, Lambs Feeding | Class 1 | Lambs Feeding, Nipple | 2006 | 8 |
| Pump, Breast, Powered | Class 2 | 2010 | 40 | |
| Ring, Teething, Fluid-Filled | Class 2 | Gel Soothers, Ice Gel Teethers, Water Filled Cooling Gum Soother, Ice Gel Soothers | 2009 | 18 |
| Ring, Teething, Non-Fluid Filled | Class 1 | Nuby, Parent’s Choice, LUV N’care, Teething, NON-Fluid Filled, Ring | 2006 | 42 |
| Syringe, Irrigating (Non Dental) | Class 1 | Medicine Syringe | 2003 | 110 |
Clearances
No clearance names Dongguan Qing Xi Essentia Industries Ltd as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K100385 | 2010-03-24 | HGX | Traditional | LUV N’ Care, Ltd. |
| K092494 | 2010-03-01 | KKO | Traditional | LUV N’ Care, Ltd. |
| K981202 | 1998-06-16 | KKO | Traditional | Corium Corp. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.