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Guangzhou Ajax Medical Equipment Co Ltd: FDA-registered device maker in Guangzhou Guangdong, China, 4 510(k) clearances

Name: Guangzhou Ajax Medical Equipment Co Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Guangzhou Ajax Medical Equipment Co Ltd is registered with the FDA (registration 3010446656) in Guangzhou Guangdong, China. It lists 13 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 12, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Guangzhou Ajax Medical Equipment Co Ltd

FDA registration number: 3010446656
Address: Building No.2 Dagang industrial zone Shilou Town, Panyu District, Guangzhou Guangdong, China, 511447
Owner or operator: GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD (10048168)
Roles: Manufacturer
First device listed: December 12, 2014
Registered through: 2026
Brand names listed: AJEM1; AJEM2; AJEM3, Beyond 300 Continental, Beyond 400 Continental, Cassette Autoclave(Model:ACA5), Classic 100,Classic 101,Classic 200,Classic 201,Beyond 300,Beyond 301,Beyond 400,Beyond 401, Dental Chair, Dental Stool, Dental Unit(model:AJ10;AJ11;AJ12;AJ15;AJ16;AJ17;AJ18;AJ19;AJ22;AJ25;AJ26;AJ28,AJ21,AJ27), Dental X-RAY Unit(Model:AJX200, AJX100, AJX300, AJX400, AJX500, AJX600, AJX700), EOS Extraoral Suction System(model: Optima 350, EOS, EOS Plus, Thor, Thor-s) and more

Devices it lists

Device	Product code	Class	Role	Source
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Manufacturer	accessdata.fda.gov
Lamp, Operating-Room	FQP	2	Manufacturer	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Manufacturer	accessdata.fda.gov
Purifier, Air, Ultraviolet, Medical	FRA	2	Manufacturer	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Manufacturer	accessdata.fda.gov
Unit, Suction Operatory	EBR	1	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 12, 2026	K252110	Dental X-RAY Unit (AJX200)	EHD	Substantially Equivalent	Guangzhou Ajax Medical Equipment Co., Ltd.	accessdata.fda.gov
August 14, 2025	K250164	Cassette Autoclave (ACA5)	FLE	Substantially Equivalent	Guangzhou Ajax Medical Equipment Co., Ltd.	accessdata.fda.gov
June 11, 2021	K202766	EOS Air Cleaner	FRA	Substantially Equivalent	Guangzhou Ajax Medical Equipment Co., Ltd.	accessdata.fda.gov
September 5, 2014	K132245	AJAX DENTAL UNIT	EIA	Substantially Equivalent	Pro Dental Services, LLC	accessdata.fda.gov

Compare with other makers

Updated March 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.