Essentia Industries Ltd.
Registered establishment in Dong Guan, Guangdong, China. 31 device types.
Essentia Industries Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Sling, Arm and 29 other device types. Its earliest product listing with the FDA dates from 2007.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009124884 |
| FEI number | 3009124884 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Dong Guan |
|---|---|
| Province | Guangdong |
| Address | Building 2, No. 94, Yanhe East 1st Road, DongKeng Town |
| Postal code | 523455 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Nasal Aspirator | 2020 | 58 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | cotton applicator | 2011 | 186 |
| Bandage, Elastic | Class 1 | stretch bandage | 2007 | 280 |
| Catheters, Suction, Tracheobronchial | Class 1 | Nasal aspirator | 2010 | 93 |
| Container, Liquid Medication, Graduated | Class 1 | medicine spoon | 2007 | 68 |
| Continuous Measurement Thermometer | Class 2 | digital thermometer | 2008 | 115 |
| Cover, Cast | Class 1 | cast cover | 2007 | 31 |
| Dispenser, Liquid Medication | Class 1 | Medicine syringe, medicine pacifier | 2007 | 86 |
| Dispenser, Solid Medication | Class 1 | pill dispenser | 2007 | 68 |
| Massager, Therapeutic, Electric | Class 1 | powered massager | 2007 | 437 |
| Massager, Therapeutic, Manual | Class 1 | Gum massager | 2009 | 113 |
| Mirror, Mouth | Class 1 | baby mouth mirror, Dental Mirror | 2007 | 94 |
| Otoscope | Class 1 | digital ear thermometer | 2007 | 43 |
| Pack, Hot Or Cold, Reusable | Class 1 | cold compress | 2007 | 178 |
| Pick, Massaging | Class 1 | GUM Stimulator | 2007 | 46 |
| Pill Crusher/Cutter | Class 1 | pill cutter | 2010 | 41 |
| Pump, Breast, Non-Powered | Class 1 | Silicone Breast Pump, Limerick LOVE Hand Pump | 2018 | 33 |
| Pump, Breast, Powered | Class 2 | PJ’s Comfort Portable Electric Breast Pum, PJ’s Serenity | 2025 | 40 |
| Reminder, Medication | Class 1 | medication minder | 2007 | 15 |
| Ring, Teething, Fluid-Filled | Class 2 | Sassy Waterfill teethers, Handi-craft waterfill teether | 2020 | 18 |
| Ring, Teething, Non-Fluid Filled | Class 1 | Doctor Brown Teether (normal) | 2008 | 42 |
| Scissors, Medical, Disposable | Class 1 | baby scsissors | 2007 | 36 |
| Shield, Nipple | Class 1 | Nipple Shields | 2019 | 15 |
| Sling, Arm | Class 1 | arm sling | 2007 | 126 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | arm/leg splint | 2007 | 62 |
| Strip, Temperature, Forehead, Liquid Crystal | Class 2 | forehead thermometer strip | 2011 | 17 |
| Syringe, Ent | Class 1 | medicine dropper | 2007 | 24 |
| Syringe, Irrigating (Non Dental) | Class 1 | Medicine dispensing syringe | 2013 | 110 |
| Tip, Rubber, Oral Hygiene | Class 1 | Oral Care Kits | 2013 | 18 |
| Toothbrush, Manual | Class 1 | Toothbrush | 2007 | 244 |
| Toothbrush, Powered | Class 1 | Gentle Vibrations Toothbrush | 2007 | 191 |
Clearances
No clearance names 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 |
|---|---|---|---|---|
| K021851 | 2002-07-17 | FLL | Abbreviated | K-Jump Health Co., Ltd. |
| K984551 | 2000-01-14 | FLL | Traditional | K-Jump Health Co., Ltd. |
| K893803 | 1989-08-21 | KPD | Traditional | Liquid Crystal Sciences, Inc. |
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.