Data / Medical devices / Vietnam / ONFU electronics Co., LTD.

ONFU electronics Co., LTD.: FDA-registered device maker in Trang Bom Dong Nai, Vietnam, 12 510(k) clearances

Name: ONFU electronics Co., LTD. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ONFU electronics Co., LTD. is registered with the FDA (registration 3016867013) in Trang Bom Dong Nai, Vietnam. It lists 3 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 6, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016867013
Address: Street No.3, Song May Industrial Zone, Binh Minh Commune, Trang Bom Dong Nai, Vietnam, 76000
Owner or operator: MICROLIFE CORP. (8020605)
Roles: Contract manufacturer, Manufacturer
First device listed: December 5, 2007
Registered through: 2026
Brand names listed: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Fertility Diagnostic, Proceptive	LHD	U	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Contract manufacturer, 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 6, 2025	K251120	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)	DXN	Substantially Equivalent	Microlife Corporation	accessdata.fda.gov
June 28, 2023	K230075	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K	DXN	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
May 19, 2023	K222979	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W	DXN	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
November 4, 2021	K211288	Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B	DXN	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
August 30, 2017	K170467	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	DXN	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
July 14, 2015	K151330	Microlife Wrist Watch Blood Pressure Monitor	DXN	Substantially Equivalent	Microlife Intellectual Property GmbH, Switzerland	accessdata.fda.gov
July 13, 2011	K111652	MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
June 10, 2009	K091589	MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1	FLL	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
December 9, 2004	K043110	MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1	FLL	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
February 23, 2004	K033820	MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1	FLL	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
September 12, 2003	K030961	MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921	LHD	Substantially Equivalent	Microlife Corp.	accessdata.fda.gov
May 23, 1985	K851146	DIGITAL THERMOMETER	FLL	Substantially Equivalent	Micro Idea Instrument Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 6, 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.