Manufacturer Intelligence · Based on 66,949 FDA 510(k) records · 74 countries

FDA 510(k) Medical Device Manufacturers - Hong Kong

Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

Hong Kong medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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Manufacturers

Hong Kong

Country

Hong Kong FDA 510(k) Overview

Manufacturers

Submissions

100%

Clearance rate

Leading Hong Kong FDA 510(k) manufacturers include Bioland Technology, Ltd., Well-Life Healthcare Limited, Belun Technology Company Limited and 11 others.

Hong Kong-based medical device manufacturers have submitted 29 FDA 510(k) notifications since 2018, with a 100% clearance rate across 14 manufacturers. Hong Kong's medtech sector primarily serves as a regional hub for manufacturers targeting both U.S. and Asia-Pacific markets, with activity in diagnostics, monitoring devices and Class II medical equipment.

Active in FDA 510(k) submissions since 2018. Many Hong Kong manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Hong Kong Manufacturers

1–14 of 14

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Bioland Technology, Ltd. North Point	7	100%	CH CV HO	HK
2	Well-Life Healthcare Limited Kowloon	5	100%	GU NE	HK
3	Belun Technology Company Limited Sha Tin	5	100%	AN	HK
4	PanopticAI technologies Limited Hong Kong	2	100%	CV	HK
5	Tyece , Ltd. Kowloon	1	100%	NE	HK
6	Kea Products, Ltd. Kwun Tong	1	100%	DE	HK
7	Alleva Medical (D.G), Ltd. Shek Mun	1	100%	CV	HK
8	Innonix Technologies Limited Siu Lek Yuen,Shatin	1	100%	HO	HK
9	Perfection Aligner System Hong Kong Limited Kowloon, Hongkong	1	100%	DE	HK
10	Wilson Tech (International) Limited Kowloon	1	100%	HO	HK
11	Iluminage Beauty Co., Limited Wan Chai	1	100%	SU	HK
12	Alleva Medical, Ltd. Shek Mun	1	100%	SU	HK
13	Vincent Healthcare Products Limited Hung Hom	1	100%	AN	HK
14	Pacific Care Limited N.T.	1	100%	DE	HK

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.