HomeChinaHUA YUE MEDICAL TECHNOLOGY CO., LTD.

HUA YUE MEDICAL TECHNOLOGY CO., LTD.

China · Guangzhou Guangdong
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, South Korea, Australia, Russia — 5 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
7listed device types
Class I 1Class II 6Class III 0
plus 5 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 1Class II 5
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Business type not stated 1
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States5 registration records, 2 510(k), 0 PMA, 9 excluded
Brazil6 confirmed, 0 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: HUA YUE MEDICAL TECHNOLOGY CO., LTD. · HUA YUE MEDICAL TECHNOLOGY 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

12025 · K242684
12026 · K253333

FDA listed device types

Assisted Reproduction Laminar Flow Workstation 1Accessory, Assisted Reproduction, Exempt 1Accessory, Assisted Reproduction 1Labware, Assisted Reproduction 1System, Assisted Reproduction Laser 1Micromanipulators And Microinjectors, Assisted Reproduction 1Microscope And Microscope Accessories, Reproduction, Assisted 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253333Assisted Reproduction Laser System (Model ILS-400M)2026-06-17
USK242684Harioculture TL-16 Time-lapse Incubator2025-05-22
BR81325990441Sistema MicromanipuladorClass I
BR81325999076Estação de Trabalho de FIVClass II
BR81325999060Incubadora de BancadaClass II

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →