Guangzhou Ajax Medical Equipment Co Ltd
Manufacturer and brand owner in Guangzhou, Guangdong, China. 13 device types, 4 products catalogued, 3 clearances.
Guangzhou Ajax Medical Equipment Co Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Sterilizer, Steam, Lamp, Operating-Room and 11 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010446656 |
| FEI number | 3010446656 |
| DUNS | 547897476 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广州艾捷斯医疗器械有限公司 |
|---|---|
| Unified social credit code | 914401136659097377 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Building No.2 Dagang industrial zone |
| Postal code | 511447 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | Class 1 | Dental Chair, Dental Stool | 2019 | 38 |
| Cleaner, Ultrasonic, Medical Instrument | Class 1 | Ultrasonic Cleaner(Model:AUC3.5, AUC4, AUC6, AUC15, AUC22) | 2025 | 48 |
| Lamp, Operating-Room | Class 2 | LED Sugical Light | 2020 | 14 |
| Light, Operating, Dental | Class 1 | LED Dental Light(model: Amber, Amber II, Pebble, Pebble II, Hubble, Hubble II, Leo, Libra, Whale) | 2019 | 16 |
| Motor, Surgical Instrument, Ac-Powered | Class 1 | AJEM1; AJEM2; AJEM3 | 2025 | 7 |
| Purifier, Air, Ultraviolet, Medical | Class 2 | EOS Extraoral Suction System(model: Optima 350, EOS, EOS Plus, Thor, Thor-s) | 2021 | 2 |
| Sterilizer, Steam | Class 2 | Cassette Autoclave(Model:ACA5) | 2025 | 3 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | Intraoral Scanner(Model: AJS1, AJS2, AJS3) | 2025 | 36 |
| Table, Operating-Room, Electrical | Class 1 | Surgical Chair, Operating Table(model:AA6688) | 2021 | 29 |
| Unit, Operative Dental | Class 1 | Dental Unit(model:AJ10;AJ11;AJ12;AJ15;AJ16;AJ17;AJ18;AJ19;AJ22;AJ25;AJ26;AJ28,AJ21,AJ27), Portable Delivery System, Self Contained Enlarged Orthodontic Mobile Cart OC-2, Mobile Cart, Beyond 300 Continental, Beyond 400 Continental, ultima 800, ultima 801 and 1 more | 2014 | 13 |
| Unit, Operative Dental, Accessories | Class 1 | Oil Free Air Compressor(model:BA100;BA200;BA220;BA300;BA400;BA600;BA1000;BA1200;AT200;AT260;AT300;AT400;AT600;AT1000), Suction System, Dry Vaccum System(model: SV300,SV400,SV600,SV800,SV1000,PV100), Oil Free Air Compressor(model: UA200;UA300;UA400;UA600;UA900;UA1000;UA1200;AT800;BA800;AT20P;AT40P;AT60P;AT80P;AT100P), Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14), Oil Free Air Compressor(model: AJAX100;AJAX200;AJAX300;AJAX400;AJAX600;AJAX800;AJAX1000) | 2019 | 65 |
| Unit, Suction Operatory | Class 1 | Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14), Suction System, Dry Vaccum System(model: SV300,SV400,SV600,SV800,SV1000,PV100,V20,V40,V60,V80,V100), Suction System, Dry Vaccum System(model: DV600,DV800,DV1000,DV1500), Suction System, Dry Vaccum System(model: WV200,WV400,WV600) | 2020 | 23 |
| Unit, X-Ray, Extraoral With Timer | Class 2 | Dental X-RAY Unit(Model:AJX200, AJX100, AJX300, AJX400, AJX500, AJX600, AJX700) | 2026 | 8 |
Own-Brand Listings
Clearances
3 clearances name Guangzhou Ajax Medical Equipment Co Ltd as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252110 | 2026-03-12 | EHD | Traditional | This company |
| K250164 | 2025-08-14 | FLE | Traditional | This company |
| K202766 | 2021-06-11 | FRA | Traditional | This company |
| K132245 | 2014-09-05 | EIA | Traditional | Pro Dental Services, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Dental treatment units, Operatory room systems, Imaging systems, Teaching systems, Intraoral scanners |
|---|---|
| Certifications | National-level Specialized and Innovative Little Giant |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.