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Wuhan Huchuang Union Technology Co., Ltd.: FDA-registered device maker in Wuhan Hubei, China, 1 510(k) clearance

Name: Wuhan Huchuang Union Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Wuhan Huchuang Union Technology Co., Ltd. is registered with the FDA (registration 3023235140) in Wuhan Hubei, China. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 7, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3023235140
Address: Building10, No.818 Gaoxin Avenue, Wuhan Hubei, China, 430206
Owner or operator: Wuhan Huchuang Union Technology Co., Ltd. (10084962)
Roles: Exporter to the US, Manufacturer
First device listed: April 20, 2022
Registered through: 2026
Brand names listed: Assisted Reproduction Micropipettes, Pasteur Pipettes, Droplet preparation Instrument, Incubator DCK900, Incubator DCK1000, Incubator DCK6, Incubator DCK10,, Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004), IVF Certified Dish, Specimen Containers, Test Tube, Conical Tube, Warming Equipment, Incubator DCKMiniA, Incubator CH60R, Incubator CH60L, Micromanipulation System, Workstation

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Assisted Reproduction	MQG	2	Exporter to the US, 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	Exporter to the US, Manufacturer	accessdata.fda.gov
Labware, Assisted Reproduction, Exempt	PUD	2	Manufacturer	accessdata.fda.gov
Micromanipulators And Microinjectors, Assisted Reproduction	MQJ	2	Manufacturer	accessdata.fda.gov
Microscope And Microscope Accessories, Reproduction, Assisted	MTX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Microtools, Assisted Reproduction (Pipettes), Exempt	PUC	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
May 7, 2024	K232493	Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)	MQG	Substantially Equivalent	Wuhan Huchuang Union Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 7, 2024. 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.