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Hongkong Conlight Medical Group Limited: FDA-registered device maker in Tai Kok Tsui Hong Kong, China, 1 510(k) clearance

Name: Hongkong Conlight Medical Group Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hongkong Conlight Medical Group Limited is registered with the FDA (registration 3034694973) in Tai Kok Tsui Hong Kong, China. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3034694973
Address: Rm 509 5/F THE CLOUD 111 TUNG CHAU ST, Tai Kok Tsui Hong Kong, China, 999077
Owner or operator: HongKong Conlight Medical Group Limited (10092121)
Roles: Manufacturer, Specification developer
First device listed: December 6, 2024
Registered through: 2026
Brand names listed: Accurature Multi-drug Urine Test Dip Card, Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup,, Strip, Test Isoniazid

Devices it lists

Device	Product code	Class	Role	Source
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Manufacturer, Specification developer	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Manufacturer, Specification developer	accessdata.fda.gov
Strip, Test Isoniazid	MIG	U	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
February 23, 2024	K232228	Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card	DJG	Substantially Equivalent	Shanghai Accurature Diagnostics Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 23, 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.