Manufacturer Intelligence · Based on 150,837 FDA 510(k) records · 85 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.

Compare manufacturers by FDA 510(k) submission activity
Identify clearance rates, active panels and years of FDA activity
Filter by country or FDA review panel specialty

Manufacturers

Belgium

Country

Belgium FDA 510(k) Overview

Manufacturers

220

Submissions

98%

Clearance rate

Leading Belgium FDA 510(k) manufacturers include Materialise NV, Terumo Europe N.V., Agfa Healthcare N.V. and 44 others.

Belgian medical device manufacturers have submitted 220 FDA 510(k) notifications since 1994, achieving a 98.2% clearance rate across 47 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 1994. Many Belgium manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Belgium Manufacturers

1–47 of 47

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Materialise NV Leuven	61	100%	DE NE OR +1	BE
2	Terumo Europe N.V. Leuven	28	100%	CH HO	BE
3	Agfa Healthcare N.V. Mortsel	27	100%	RA SU	BE
4	Barcoview Kortrijk	17	100%	RA	BE
5	Orfit Industries NV Wijnegem	9	100%	RA	BE
6	Cefaly Technology Herstal	6	100%	NE	BE
7	Agfa N.V. Mortsel	6	100%	RA	BE
8	Barcoview, Medical Imaging Systems Kortrijk	5	100%	RA	BE
9	Materialise Dental NV Leuven	5	100%	RA	BE
10	Icometrix NV Leuven	4	100%	RA	BE
11	Feops NV Gent-Zwijnaarde	4	75%	CV RA	BE
12	Ectosense NV Rotselaar	3	100%	AN	BE
13	3D-Side S.A. Mont-Saint-Guibert	3	100%	OR RA	BE
14	Endo Tools Therapeutics S.A. Gosselies	2	100%	GU	BE
15	Medinvents Hasselt, Limburg	2	100%	GU	BE
16	Orfit Industries Wijnegem, Belgium	2	100%	RA	BE
17	Icometrix Leuven	2	100%	RA	BE
18	Qompium NV Hasselt	2	100%	CV	BE
19	G-Flex Europe Sprl Nivelles	2	100%	GU	BE
20	Sunrise SA Namur	2	100%	AN	BE
21	Relu BV Leuven	2	100%	DE RA	BE
22	Clouds of Care Ghent	1	100%	NE	BE
23	Standard Engineering 3053 Haasrode	1	100%	CH	BE
24	Uniphy Elektromedizin GmbH & Co. KG Bilzen	1	100%	SU	BE
25	Nomics Angleur, Liege	1	100%	RA	BE
26	Stx-Med Sprl Herstal, Liege	1	0%	NE	BE
27	Barco Kortrijk	1	100%	RA	BE
28	Ion Beam Application S.A. Louvain-La-Neuve	1	100%	RA	BE
29	Janssen Pharmaceutica NV Beerse	1	100%	MI	BE
30	Epilog Ghent	1	100%	NE	BE
31	Diagenode Seraing	1	100%	MI	BE
32	Bioncise NV Wellen	1	100%	OB	BE
33	Medxpress.Pro Leuven	1	100%	RA	BE
34	Byteflies NV Antwerp	1	100%	NE	BE
35	Sunrise Namur	1	0%	AN	BE
36	Biocartis NV Mechelen	1	100%	PA	BE
37	Wishbone SA Flemalle	1	100%	DE	BE
38	Bloom Technologies NV Genk	1	100%	OB	BE
39	Myocene Li?ge	1	0%	PM	BE
40	Xeos Medical Gent	1	100%	RA	BE
41	Oystershell NV Merelbeke	1	100%	SU	BE
42	Zinkh NV Gent	1	100%	DE	BE
43	3D-Side Mont-Saint-Guibert	1	100%	OR	BE
44	Midiagnostics NV Leuven	1	100%	MI	BE
45	Nobel Biocare C/O Medicim NV Mechelen	1	100%	RA	BE
46	Barco NV Kortrijk	1	100%	RA	BE
47	Replasia BV Leuven	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.