FDA Registration
Active
🇨🇳 China
Aimi Health Technology (Guangdong) Co., Ltd.
Reg #: 3010683450
·
FEI: 3010683450
·
Expires 2026
Products
21
Proprietary Names
44
Establishment Types
2
Classifications
21
Registration Details
- Registration Name
- Aimi Health Technology (Guangdong) Co., Ltd.
- Registration Number
- 3010683450
- FEI Number
- 3010683450
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 1, No.77 Cuihu Road, Chigang, Humen Town
- City
- Dongguan City Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Aimi Health Technology (Guangdong) Co., Ltd.
- Operator Number
- 10061475
- Address
- Building 1, No.77 Cuihu Road, Chigang, Humen Town
- City
- Dongguan City
- State
- Guangdong
- Postal Code
- 523932
- Country
- CN
- Correspondent
- Lisa Liao
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oral Irrigation Kit | OGT | Class 1 | Dental | No | 2025-12-19 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2022-01-07 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2026-03-26 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2022-01-07 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2022-01-07 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2022-01-07 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2022-01-07 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2022-01-07 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-04-01 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2026-03-26 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2025-12-19 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2022-01-07 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-12-19 |
| Douche Apparatus, Vaginal, Therapeutic | HED | Class 1 | Obstetrics/Gynecology | No | 2022-01-07 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2025-12-19 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2019-10-22 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2019-10-22 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2019-10-22 |
| Ear Irrigation Kit | OGQ | Class 1 | General Hospital | No | 2022-01-07 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2025-12-19 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2025-12-19 |
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,
AOE11, AOE12, AOE13, AOE14, AOE15, AOE16, AOE17, AOE18, AOE19, AOE20
HX6013;HX6014;HX6024;HX6064;HX6074;HX7001;HX2012; ATA1S )
(Electric Toothbrush,Sonic Toothbrush, Replacement Brush Head:
AOE01Pro;AOE02Pro;AOE03Pro;AOE04Pro;AOE05Pro AOKO1,AOK02,AOK03,AOKO4
AOK02Pro;AOK01Pro;AOKO3Pro,AOKO4Pro AOB03,AOB04,AOB05,AOB06
EB-17-X/EB-17-XS/EB20-X/EB22-X/EB28-X/EB50-X/EB52-X/EB55-X/EB60-X/EB62-X
EB20-P;SB-20A;EB-25A;EB-30A;SB-417A; EB-50A;
AOE01;AOE02;AOE03;A0E04,A0E05,A0E06,AOE07,AOE08,AOE09,AOE10
SB-17A,EB-17C;EB17-P;EB-17D,EB18-P,EB-18A; EB25-P; EB28-P; EB50-P;
AON09, AON10, AON11, AON12, AON13, AON14, AON15, AON16, AON17, AON18, AON19, AON20, AON09Pro, AON10Pro, AON11Pro,
AON12Pro, AON13Pro, AON14Pro, AON15Pro, AON16Pro, AON17Pro, AON18Pro, AON19Pro, AON20Pro
(Nasal Irrigator, Nasal Wash Bottle:
250ML/300ML/500ML; AON01;AON02;AON03;AON04;AON01Pro;AON02Pro AON03Pro;AON04Pro
AON05, AON06, AON07, AON08, AON05Pro, AON06Pro, AON07Pro, AON08Pro)
Ear irrigation kit, AOF01, AOF02, AOF03, AOF04, AOF05
SHIELD, EYE, RADIOLOGICAL
Vaginal Douche, Body Wash Bottle ED300
SYRINGE, IRRIGATING (NON DENTAL)-PORTABLE BIDET, POSTPARTUM CARE, Vaginal Cleansing System, Syringe,
Irrigating (Non Dental), Vaginal irrigator, Woman washer, Woman washer bidet, PERSONAL HYGIENE CARE, vaginal cleaner,
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device