Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009124884

FEI Number

3009124884

Entity Name

Essentia Industries Ltd.

City/State/Country

Dong Guan Guangdong, CN

Establishment Address

Building 2, No. 94, Yanhe East 1st Road, DongKeng Town, Dong Guan Guangdong 523455, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

ALLIED HILL ENTERPRISES, LTD. (Owner Number: 9101920)

Owner / Operator Contact Address

STE 507, TOWER 1, SILVERCORD, 30 CANTON RD T.S.T., KOWLOON, HK-NOTA --, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nipple Shields cotton applicator arm/leg splint digital thermometer GUM STIMULATOR pill cutter medicine spoon Silicone Breast Pump Limerick LOVE Hand Pump medicine dropper GENTLE VIBRATIONS TOOTHBRUSH Medicine dispensing syringe Toothbrush digital thermometer stretch bandage Nasal Aspirator DENTAL MIRROR baby mouth mirror Oral Care Kits PJ's Comfort Portable Electric Breast Pum Nasal aspirator arm sling forehead thermometer strip Doctor Brown Teether (normal) baby scsissors digital ear thermometer Gum massager PJ's Serenity powered massager Handi-craft waterfill teether Sassy Waterfill teethers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2019-06-23
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-05-04
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2007-06-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-05-04
JET	Pick, Massaging	Dental	Class 1	872.6650	2007-05-22
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2010-03-01
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2007-06-15
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2018-10-18
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2007-05-22
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2007-05-22
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2013-04-30
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2007-05-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-10-08
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2007-07-24
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2020-11-04
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2007-05-22
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2013-04-30
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-08-18
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2010-12-01
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2007-07-24
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2011-05-04
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2008-10-06
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2007-07-24
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2007-06-15
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2009-04-07
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-08-18
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2007-06-15
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2020-05-21

Official Correspondent

No official correspondent registered.

US Agent Details

Paul Ware Business: PW Resources, Inc. Email: paware46@spectrum.net Phone: (617) 5137253

Related Public Records

Same Entity

ALLIED HILL ENTERPRISES, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010337881	Allied Hill Enterprises, Ltd.	Hong Kong, HK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009124884. Last updated year: 2026. Please use registration number 3009124884 when referencing this establishment in official correspondence.