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Hua Yue Medical Technology Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 2 510(k) clearances

Name: Hua Yue Medical Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hua Yue Medical Technology Co., Ltd. is registered with the FDA (registration 3031594904) in Guangzhou Guangdong, China. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 17, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3031594904
Address: First Floor, C2 building, No.11 Kaiyuan Road, Huangpu District, Guangzhou Guangdong, China, 510530
Owner or operator: Hua Yue Medical Technology Co., Ltd. (10090985)
Roles: Manufacturer
First device listed: June 11, 2024
Registered through: 2027
Brand names listed: Assisted Reproduction Laser System (Model ILS-400M), Benchtop Incubator(Model IBI-D101,Harioculture DI-4, Harioculture HI-2, Harioculture HI-4), Harioculture TL-16 Time-lapse Incubator, Hariomed Culture Dish, Hariomed Humidification Box, IVF Workstation, Micromanipulator System (Model IMS-320D, IMS-320D-S, IMS-320U, IMS-320U-S), Time-lapse Incubator Capacity Expansion Module

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Assisted Reproduction	MQG	2	Manufacturer	accessdata.fda.gov
Accessory, Assisted Reproduction, Exempt	PUB	2	Manufacturer	accessdata.fda.gov
Assisted Reproduction Laminar Flow Workstation	QKH	2	Manufacturer	accessdata.fda.gov
Labware, Assisted Reproduction	MQK	2	Manufacturer	accessdata.fda.gov
Micromanipulators And Microinjectors, Assisted Reproduction	MQJ	2	Manufacturer	accessdata.fda.gov
Microscope And Microscope Accessories, Reproduction, Assisted	MTX	1	Manufacturer	accessdata.fda.gov
System, Assisted Reproduction Laser	MRX	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
June 17, 2026	K253333	Assisted Reproduction Laser System (Model ILS-400M)	MRX	Substantially Equivalent	Hua Yue Medical Technology Co., Ltd.	accessdata.fda.gov
May 22, 2025	K242684	Harioculture TL-16 Time-lapse Incubator	MQG	Substantially Equivalent	Hua Yue Medical Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 17, 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.