HomeChinaGuangzhou Ajax Medical Equipment Co., Ltd.

Guangzhou Ajax Medical Equipment Co., Ltd.

China · Guangzhou Guangdong
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, South Korea, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
13listed device types
Class I 8Class II 5Class III 0
plus 13 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
Class I 1IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States13 registration records, 3 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia3 confirmed, 0 excluded
Manufacturer names merged into this page: GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTD · GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTD. · Guangzhou Ajax Medical Equipment Co., Ltd. · Guangzhou Ajax Medical Equipment Co Ltd

Company information

Country
China
City
Guangzhou Guangdong

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12021 · K202766
12025 · K250164
12026 · K252110

FDA listed device types

showing 8 of 13
Motor, Surgical Instrument, Ac-Powered 1Unit, Operative Dental 1Unit, Operative Dental, Accessories 1Light, Operating, Dental 1Unit, Suction Operatory 1Cleaner, Ultrasonic, Medical Instrument 1Table, Operating-Room, Electrical 1Chair, Dental, Without Operative Unit 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252110Dental X-RAY Unit (AJX200)2026-03-12
USK250164Cassette Autoclave (ACA5)2025-08-14
USK202766EOS Air Cleaner2021-06-11
BR80430080022CADEIRAS ODONTOLÓGICAS AJAXClass I
SAME0000018232SFDAA00003Extraoral Dental Suction System
SAME0000018232SFDAA00004Ajax Dental Unit

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