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Data / Medical devices / China / Essentia Industries Ltd.

Essentia Industries Ltd.: FDA-registered device maker in Dong Guan Guangdong, China, 3 510(k) clearances

Essentia Industries Ltd. is registered with the FDA (registration 3009124884) in Dong Guan Guangdong, China. It lists 31 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 17, 2002. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3009124884
Address
Building 2, No. 94, Yanhe East 1st Road, DongKeng Town, Dong Guan Guangdong, China, 523455
Owner or operator
ALLIED HILL ENTERPRISES, LTD. (9101920)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
May 22, 2007
Registered through
2027
Brand names listed
DENTAL MIRROR, Doctor Brown Teether (normal), GENTLE VIBRATIONS TOOTHBRUSH, GUM STIMULATOR, Gum massager, Handi-craft waterfill teether, Limerick LOVE Hand Pump, Medicine dispensing syringe and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Cover, CastKIA1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dispenser, Solid MedicationNXB1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Massager, Therapeutic, ManualLYG1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
OtoscopeERA1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Pick, MassagingJET1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pill Crusher/CutterOHY1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pump, Breast, Non-PoweredHGY1Manufactureraccessdata.fda.gov
Pump, Breast, PoweredHGX2Contract manufactureraccessdata.fda.gov
Reminder, MedicationNXQ1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Ring, Teething, Fluid-FilledKKO2Contract manufacturer, Manufactureraccessdata.fda.gov
Ring, Teething, Non-Fluid FilledMEF1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Shield, NippleHFS1Manufactureraccessdata.fda.gov
Sling, ArmILI1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Strip, Temperature, Forehead, Liquid CrystalKPD2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Syringe, EntKCP1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufactureraccessdata.fda.gov
Tip, Rubber, Oral HygieneJEW1Manufactureraccessdata.fda.gov
Toothbrush, ManualEFW1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Toothbrush, PoweredJEQ1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 17, 2002K021851DIGITAL CLINICAL THERMOMETER, MODEL KD-193FLLSubstantially EquivalentK-Jump Health Co., Ltd.accessdata.fda.gov
January 14, 2000K984551INFRARED EAR THERMOMETER, MODEL KI-8120FLLSubstantially EquivalentK-Jump Health Co., Ltd.accessdata.fda.gov
August 21, 1989K893803FEVER LINE AND FEVER LINE PLUSKPDSubstantially EquivalentLiquid Crystal Sciences, Inc.accessdata.fda.gov

Compare with other makers

Updated July 17, 2002. 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.