Manufacturer registered with FDA
Aimi Health Technology (Guangdong) Co., Ltd.
Dongguan City, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Aimi Health Technology (Guangdong) Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Aimi Health Technology (Guangdong) Co., Ltd. | 5 device types | — | Below |
| Brazil | ANVISA | Manufacturer | AIMI HEALTH TECHNOLOGY (GUANGDONG) CO.,LTD | 1 | 2024–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Aimi Health Technology (Guangdong) Co., Ltd. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Aimi Health Technology (Guangdong) Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | HEAT SOURCE FOR BLEACHING TEETH-Teeth Whitening Kit | 2022 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | AO W29Pro, AOW30Pro, OCAN09plus, AOW09PlusAOW02,AOW03,AOW04,AOW05,AOW06, AOW07,AOWO1Pro;AOW02Pro;AOW3ProAOW04Pro;AOW05Pro;AOW06Pro;AOW07Pro;EWF003AOW08, AOW09, AOW10, AOW11, AOW12, AOW08Pro; AOW09Pro; AOW10Pro; AOW11ProAOW13, AOW14, AOW15, AOW13Pro, AOW14Pro, AOW15ProAOW16, AOW17, AOW18, AOW19, AOW20, AOW21, AOW22, AOW23, AOW24, AOW25, AOW26, AOW27, AOW28, AO W29, AOW30, AOW16Pro,AOW17Pro, AOW18Pro, AOW19Pro, AOW20Pro, AOW21Pro, AOW22Pro, AOW23Pro, AOW24Pro, AOW25Pro, AOW26Pro, AOW27Pro, AOW28Pro,Oral Irrigator, Water Flosser, Dental Oral Irrigator, Jet Tips, Dental Water Jet: AOW01 | 2019 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | SCALER,PERIODONTIC-PERSMAX Ultrasonic Electric Dental Scaler, AOJ01, AOJ02, AOJ03, AOJ04, AOJ05 | 2022 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | AOE01;AOE02;AOE03;A0E04,A0E05,A0E06,AOE07,AOE08,AOE09,AOE10AOE01Pro;AOE02Pro;AOE03Pro;AOE04Pro;AOE05Pro AOKO1,AOK02,AOK03,AOKO4AOE11, AOE12, AOE13, AOE14, AOE15, AOE16, AOE17, AOE18, AOE19, AOE20AOK02Pro;AOK01Pro;AOKO3Pro,AOKO4Pro AOB03,AOB04,AOB05,AOB06EB-17-X/EB-17-XS/EB20-X/EB22-X/EB28-X/EB50-X/EB52-X/EB55-X/EB60-X/EB62-XEB20-P;SB-20A;EB-25A;EB-30A;SB-417A; EB-50A;HX6013;HX6014;HX6024;HX6064;HX6074;HX7001;HX2012; ATA1S )SB-17A,EB-17C;EB17-P;EB-17D,EB18-P,EB-18A; EB25-P; EB28-P; EB50-P;(Electric Toothbrush,Sonic Toothbrush, Replacement Brush Head: | 2019 |
| Oral Irrigation KitOGT · Class 1 | — | Maker | Ear Nose&Throat | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Aimi Health Technology (Guangdong) Co., Ltd.FDA reg. 3010683450 | Dongguan City Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061475). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.