Manufacturer Intelligence · Based on 58,934 FDA 510(k) records · 74 countries

FDA 510(k) Medical Device Manufacturers - Belgium

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

Belgian 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

Belgium

Country

Belgium FDA 510(k) Overview

Manufacturers

Submissions

97%

Clearance rate

Leading Belgium FDA 510(k) manufacturers include Materialise NV, Terumo Europe N.V., Agfa N.V. and 30 others.

Belgian medical device manufacturers have submitted 87 FDA 510(k) notifications since 2018, achieving a 96.6% clearance rate across 33 manufacturers. Belgium's medtech sector reflects the country's strength in cardiovascular devices, in vitro diagnostics and pharmaceutical-adjacent medical technologies, supported by proximity to major European regulatory bodies.

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

FDA 510(k) Belgium Manufacturers

1–33 of 33

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Materialise NV Leuven	25	100%	DE NE OR +1	BE
2	Terumo Europe N.V. Leuven	6	100%	HO	BE
3	Agfa N.V. Mortsel	6	100%	RA	BE
4	Icometrix NV Leuven	4	100%	RA	BE
5	Feops NV Gent-Zwijnaarde	4	75%	CV RA	BE
6	Orfit Industries NV Wijnegem	3	100%	RA	BE
7	Cefaly Technology Herstal	3	100%	NE	BE
8	Ectosense NV Rotselaar	3	100%	AN	BE
9	3D-Side S.A. Mont-Saint-Guibert	3	100%	OR RA	BE
10	Endo Tools Therapeutics S.A. Gosselies	2	100%	GU	BE
11	Agfa Healthcare N.V. Mortsel	2	100%	RA	BE
12	Qompium NV Hasselt	2	100%	CV	BE
13	G-Flex Europe Sprl Nivelles	2	100%	GU	BE
14	Sunrise SA Namur	2	100%	AN	BE
15	Relu BV Leuven	2	100%	DE RA	BE
16	Clouds of Care Ghent	1	100%	NE	BE
17	Icometrix Leuven	1	100%	RA	BE
18	Epilog Ghent	1	100%	NE	BE
19	Diagenode Seraing	1	100%	MI	BE
20	Bioncise NV Wellen	1	100%	OB	BE
21	Medxpress.Pro Leuven	1	100%	RA	BE
22	Byteflies NV Antwerp	1	100%	NE	BE
23	Sunrise Namur	1	0%	AN	BE
24	Biocartis NV Mechelen	1	100%	PA	BE
25	Wishbone SA Flemalle	1	100%	DE	BE
26	Bloom Technologies NV Genk	1	100%	OB	BE
27	Myocene Li?ge	1	0%	PM	BE
28	Xeos Medical Gent	1	100%	RA	BE
29	Oystershell NV Merelbeke	1	100%	SU	BE
30	Zinkh NV Gent	1	100%	DE	BE
31	3D-Side Mont-Saint-Guibert	1	100%	OR	BE
32	Midiagnostics NV Leuven	1	100%	MI	BE
33	Nobel Biocare C/O Medicim NV Mechelen	1	100%	RA	BE

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.