Data / Medical devices / South Korea / H&abyz

H&abyz: FDA-registered device maker in Yongin-si Gyeonggi, South Korea, 5 510(k) clearances

Name: H&abyz FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

H&abyz is registered with the FDA (registration 3016674851) in Yongin-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 4, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016674851
Address: 2-dong, 41-16 Cheoinseong-ro, Namsa-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, 17118, Republic of Korea, Yongin-si Gyeonggi, South Korea, 17118
Owner or operator: H&abyz (10062737)
Roles: Contract manufacturer, Manufacturer
First device listed: March 5, 2020
Registered through: 2026
Brand names listed: A1417MCW, A1717MCW, F1417MCW, GC85A, GM85, GR40CW, GR40CWC, GR40CWD and more

Devices it lists

Device	Product code	Class	Role	Source
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Contract 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
August 4, 2025	K251223	HnX-P1, HnX-PB	IZL	Substantially Equivalent	H&abyz Co., Ltd.	accessdata.fda.gov
March 6, 2023	K223930	A1417MCW/A1717MCW/F1417MCW	MQB	Substantially Equivalent	H&abyz Co., Ltd.	accessdata.fda.gov
November 15, 2021	K213497	ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)	MQB	Substantially Equivalent	H&abyz Co., Ltd.	accessdata.fda.gov
March 12, 2021	K203188	ADD	MQB	Substantially Equivalent	H&abyz Co., Ltd.	accessdata.fda.gov
January 31, 2020	K200018	HAD1717MC	MQB	Substantially Equivalent	H&Abyz	accessdata.fda.gov

Compare with other makers

Updated August 4, 2025. 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.