FDA Registration
Active
🇨🇳 China
GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD
Reg #: 3010446656
·
FEI: 3010446656
·
Expires 2026
Products
13
Proprietary Names
25
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD
- Registration Number
- 3010446656
- FEI Number
- 3010446656
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building No.2 Dagang industrial zone, Shilou Town, Panyu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K250164
Owner / Operator
- Firm Name
- GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD
- Operator Number
- 10048168
- Address
- Building No.2 Dagang industrial zone, Shilou Town, Panyu District
- City
- Guangzhou
- State
- CN-NOTA
- Postal Code
- 511447
- Country
- CN
- Correspondent
- shenglin Li
US Agent
- Business Name
- ADS DENTAL SYSTEM INC.
- Contact Name
- QINGYUN HE
- Address
- 1590 S Milliken Ave., unit A, Ontario, CA 91761,, Ontario, California, 91761, UNITED STATES
- City
- Ontario
- State
- CA
- ZIP
- 91761
- Country
- US
- [email protected]
- Phone
- 626 6200456
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2025-08-20 |
| Purifier, Air, Ultraviolet, Medical | FRA | Class 2 | General Hospital | No | 2021-06-17 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2019-12-16 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2019-12-25 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2019-07-01 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2025-04-22 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2020-04-16 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2025-12-02 |
| Lamp, Operating-Room | FQP | Class 2 | General, Plastic Surgery | No | 2020-01-06 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2026-03-16 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2021-02-24 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2025-07-29 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2014-12-12 |
Proprietary Names
Cassette Autoclave(Model:ACA5)
EOS Extraoral Suction System(model: Optima 350, EOS, EOS Plus, Thor, Thor-s)
LED Dental Light(model: Amber, Amber II, Pebble, Pebble II, Hubble, Hubble II, Leo, Libra, Whale)
Dental Chair, Dental Stool
Suction System, Dry Vaccum System(model: SV300,SV400,SV600,SV800,SV1000,PV100)
Oil Free Air Compressor(model: AJAX100;AJAX200;AJAX300;AJAX400;AJAX600;AJAX800;AJAX1000)
Oil Free Air Compressor(model:BA100;BA200;BA220;BA300;BA400;BA600;BA1000;BA1200;AT200;AT260;AT300;AT400;AT600;AT1000)
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)
Intraoral Scanner(Model: AJS1)
Suction System, Dry Vaccum System(model: WV200,WV400,WV600)
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)
Ultrasonic Cleaner(Model:AUC3.5, AUC4, AUC6, AUC15, AUC22)
LED Sugical Light
Dental X-RAY Unit(Model:AJX200, AJX100, AJX300, AJX400, AJX500, AJX600, AJX700)
Surgical Chair, Operating Table(model:AA6688)
AJEM1; AJEM2; AJEM3
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
Beyond 300 Continental, Beyond 400 Continental
Mobile Cart
Classic 100,Classic 101,Classic 200,Classic 201,Beyond 300,Beyond 301,Beyond 400,Beyond 401
ultima 800, ultima 801
Establishment Types
Manufacture Medical Device