Data / Medical devices / Canada / Star Elite

Star Elite: FDA-registered device maker in Montreal Quebec, Canada, 7 510(k) clearances

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

Star Elite is registered with the FDA (registration 3004835896) in Montreal Quebec, Canada. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 3, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004835896
Address: 1175 Place du Frere-Andre, Montreal Quebec, Canada, H3B 3X9
Owner or operator: Star Elite Inc. (10081950)
Roles: Exporter to the US, Foreign private label distributor
First device listed: May 28, 2021
Registered through: 2026
Brand names listed: Arm Blood Pressure Monitor, Body Analysis Scale, Infrared Thermometer, Non-Contact Forehead Thermometer, Pulse Oximeter, Wrist Blood Pressure Monitor

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Body Composition	MNW	2	Exporter to the US	accessdata.fda.gov
Analyzer, Body Composition, Exempt	PUH	2	Foreign private label distributor	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	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
January 3, 2019	K180435	Arm Blood Pressure Monitor	DXN	Substantially Equivalent	Alicn Medical (Shenzhen), Inc.	accessdata.fda.gov
December 6, 2018	K173048	No-contact Forehead Thermometer	FLL	Substantially Equivalent	Dongguan Simzo Electronic Technology Co., Ltd.	accessdata.fda.gov
May 11, 2018	K180385	Infrared Body Thermometer	FLL	Substantially Equivalent	Hetaida Technology Co., Ltd.	accessdata.fda.gov
April 17, 2015	K150430	Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor	DXN	Substantially Equivalent	Fudakang Industrial Co., Ltd.	accessdata.fda.gov
January 31, 2012	K120058	TRANSTEK BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.	accessdata.fda.gov
July 15, 2011	K110928	BODY ANALYSIS SCALE, MODEL BG 17	MNW	Substantially Equivalent	Shenzhen Healthcare Electronic Technology Co., Ltd.	accessdata.fda.gov
November 10, 2008	K082641	FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL	DQA	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 3, 2019. 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.