Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010683450

FEI Number

3010683450

Entity Name

Aimi Health Technology (Guangdong) Co., Ltd.

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

Building 1, No.77 Cuihu Road, Chigang, Humen Town, Dongguan City Guangdong 523932, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Aimi Health Technology (Guangdong) Co., Ltd. (Owner Number: 10061475)

Owner / Operator Contact Address

Building 1, No.77 Cuihu Road, Chigang, Humen Town, Dongguan City, CN-GD 523932, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ear Nose&Throat HEAT SOURCE FOR BLEACHING TEETH-Teeth Whitening Kit Electric Nasal Aspirator CLEANER,ULTRASONIC MEDICAL INSTRUMENT-Ultrasonic Cleaner SCALER,PERIODONTIC-PERSMAX Ultrasonic Electric Dental Scaler, AOJ01, AOJ02, AOJ03, AOJ04, AOJ05 APPLICATOR, ENT Nasal spray, ENT delivery, Nasal spray, ENT delivery-Nasal Spray, Spray bottle, Saline Nasal Wash, Saline nasal spray, Seawater nasal spray, Nasal clean APPLICATOR, VAGINAL Cosmetology UV lamp,Electric Nail Drill with UV lamp Disinfectant, Medical Devices Powered Nasal-Electric Nasal Irrigation, Sinus cleaner IRRIGATOR, POWERED NASAL-nasal wash, nasal washer, nasal wash bottle, Nasal irrigator, Sinus irrigator, COLLECTOR OSTOMY MASSAGER, THERAPEUTIC, ELECTRIC DOUCHE APPARATUS,VAGINAL,THERAPEUTIC Humidifier, Non-Direct Patient Interface(Home-Use) Oral Irrigator, Water Flosser, Dental Oral Irrigator, Jet Tips, Dental Water Jet: AOW01 AOW02,AOW03,AOW04,AOW05,AOW06, AOW07,AOWO1Pro;AOW02Pro;AOW3Pro AOW04Pro;AOW05Pro;AOW06Pro;AOW07Pro;EWF003 AOW08, AOW09, AOW10, AOW11, AOW12, AOW08Pro; AOW09Pro; AOW10Pro; AOW11Pro AOW13, AOW14, AOW15, AOW13Pro, AOW14Pro, AOW15Pro AOW16, AOW17, AOW18, AOW19, AOW20, AOW21, AOW22, AOW23, AOW24, AOW25, AOW26, AOW27, AOW28, AO W29, AOW30, AOW16Pro, AO W29Pro, AOW30Pro AOW17Pro, AOW18Pro, AOW19Pro, AOW20Pro, AOW21Pro, AOW22Pro, AOW23Pro, AOW24Pro, AOW25Pro, AOW26Pro, AOW27Pro, AOW28Pro,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OGT	Oral Irrigation Kit	Dental	Class 1	872.6510	2025-12-19
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2022-01-07
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2026-03-26
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2022-01-07
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2022-01-07
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2022-01-07
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2022-01-07
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2022-01-07
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-04-01
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2026-03-26
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2025-12-19
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2022-01-07
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-12-19
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2022-01-07
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2025-12-19
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2019-10-22

Official Correspondent

Lisa Liao

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Aimi Health Technology (Guangdong) Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

Similar Registrations

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9616088	Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, MX
3026630	PHILIPS ORAL HEALTHCARE, LLC	Bothell, WA, US
3016872092	WENZHOU ZUOYOU MEDICAL TECHNOLOYG CO.,LTD.	Wenzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010683450. Last updated year: 2026. Please use registration number 3010683450 when referencing this establishment in official correspondence.