Data / Medical devices / China / Elung Industrial Co.ltd.
Elung Industrial Co.ltd.: FDA-registered device maker in T.S.T.,Kowloon, Hong Kong, China, 4 510(k) clearances
Elung Industrial Co.ltd. is registered with the FDA (registration 3006610790) in T.S.T.,Kowloon, Hong Kong, China. It lists 14 device types. The FDA files 4 510(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
- 3006610790
- Address
- Suite 507, Silvercord, Tower 1, 30 Canton Road, T.S.T.,Kowloon, Hong Kong, China, --
- Owner or operator
- ELUNG INDUSTRIAL CO.LTD. (9052953)
- Roles
- Exporter to the US
- First device listed
- February 1, 2003
- Registered through
- 2026
- Brand names listed
- APPARATUS, CLINICAL, ELECTRONIC, Gel Soothers, HOT OR COLD, Ice Gel Soothers, Ice Gel Teethers, LAMBS FEEDING and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 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 |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Exporter to the US | accessdata.fda.gov |
| Nipple, Lambs Feeding | FNN | 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 |
| Syringe, Irrigating (Non Dental) | KYZ | 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 |
|---|---|---|---|---|---|---|
| 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 |
| November 21, 2002 | K023711 | DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE | FLL | Substantially Equivalent | Acute Ideas Co. , 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 Pump, Breast, Non-Powered
- All makers of Pump, Breast, Powered
- All makers of Syringe, Ent
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Continuous Measurement Thermometer
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.