Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010446656

FEI Number

3010446656

Entity Name

GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Building No.2 Dagang industrial zone, Shilou Town, Panyu District, Guangzhou Guangdong 511447, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD (Owner Number: 10048168)

Owner / Operator Contact Address

Building No.2 Dagang industrial zone, Shilou Town, Panyu District, Guangzhou, CN-NOTA 511447, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14) Suction System, Dry Vaccum System(model: DV600,DV800,DV1000,DV1500)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2025-08-20
FRA	Purifier, Air, Ultraviolet, Medical	General Hospital	Class 2	880.6500	2021-06-17
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2019-12-16
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2019-12-25
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2019-07-01
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2025-04-22
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2020-04-16

Official Correspondent

shenglin Li

US Agent Details

QINGYUN HE Business: ADS DENTAL SYSTEM INC. Email: ads@adsequip.com Phone: (626) 6200456

Related Public Records

Same Entity

GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010446656. Last updated year: 2026. Please use registration number 3010446656 when referencing this establishment in official correspondence.