Medical device makers in Belgium: 94 FDA-registered establishments

Name: FDA-registered medical device makers in Belgium
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

94 establishments in Belgium are registered with the FDA to make medical devices for the US market, listing 278 device types. 52 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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BelgiumCountry

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
System, Image Processing, Radiological	LLZ	8
Frame, Spectacle	HQZ	5
Automated Radiological Image Processing Software	QIH	4
Sunglasses (Non-Prescription Including Photosensitive)	HQY	4
Syringe, Piston	FMF	3
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	3
General Purpose Reagent	PPM	3
Unit, Cryosurgical, Accessories	GEH	3
Screw, Fixation, Bone	HWC	2
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2
Medical Device Data System	OUG	2
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2
Shoulder Prosthesis, Reverse Configuration	PHX	2
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	2
Reagents, Specific, Analyte	MVU	2
Implant, Endosseous, Root-Form	DZE	2
Abutment, Implant, Dental, Endosseous	NHA	2
Set, Administration, Intravascular	FPA	2
Forceps, General & Plastic Surgery	GEN	2
Endoscopic Tissue Approximation Device	OCW	2
Retractor	GAD	2
Tape And Bandage, Adhesive	KGX	2
Template	HWT	2
Scissors, General, Surgical	LRW	2
Splint, Hand, And Components	ILH	2
Bandage, Cast	ITG	2
Dispenser, Liquid Medication	KYX	2
Bandage, Elastic	FQM	2
Orthopaedic Surgical Planning And Instrument Guides	PBF	2
Component, Cast	LGF	2
Cement, Dental	EMA	2
Film, Radiographic	IWZ	2
Orthosis, Limb Brace	IQI	2
Regulator, Pressure, Gas Cylinder	CAN	2
Shoulder Arthroplasty Implantation System	QHE	2
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2
System, Digital Image Communications, Radiological	LMD	2
Sealant, Polymerizing	NBE	2
Joint, Ankle, External Brace	ITW	2
Orthosis, Corrective Shoe	KNP	2
System, Radiation Therapy, Charged-Particle, Medical	LHN	2
Instrument, Quality-Assurance, Radiologic	LHO	2
Stimulator, Hypoglossal Nerve, Implanted, Apnea	MNQ	2
Block, Heating	JRG	2
Lice Removal Kit Containing A Solution	PUN	2
System, Suction, Lipoplasty For Removal	QPB	1
Electrosurgical, Cutting & Coagulation & Accessories	GEI	1
Laparoscope, General & Plastic Surgery	GCJ	1
Camera, Surgical And Accessories	KQM	1
Plate, Fixation, Bone	HRS	1
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	1
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	1
Plate, Bone	JEY	1
Spinal Vertebral Body Replacement Device	MQP	1
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	1
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	1
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	1
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	1
Knee Arthroplasty Implantation System	OOG	1
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	1
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	1
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	1
Driver, Wire, And Bone Drill, Manual	DZJ	1
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	1
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	1
Neurological Stereotaxic Instrument	HAW	1
Sacroiliac Joint Fixation	OUR	1
Radioimmunoassay, Estradiol	CHP	1
Radioimmunoassay, Luteinizing Hormone	CEP	1
Radioimmunoassay, Prolactin (Lactogen)	CFT	1
Radioimmunoassay, Total Triiodothyronine	CDP	1
Calibrator, Primary	JIS	1
Radioimmunoassay, Progesterone	JLS	1
Introducer, Catheter	DYB	1
Device, Intravascular Catheter Securement	KMK	1
Clamp, Vascular	DXC	1
Curette	HTF	1
Needle, Hypodermic, Single Lumen	FMI	1
Instrument, Biopsy	KNW	1
Instrument, Ligature Passing And Knot Tying	HCF	1
Warmer, Thermal, Infusion Fluid	LGZ	1
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	MAY	1
Catheter, Intravascular, Diagnostic	DQO	1
Instrument, Surgical, Non-Powered	HAO	1
Endoscopic Guidewire, Gastroenterology-Urology	OCY	1
Catheters, Suction, Tracheobronchial	BSY	1
Calculator, Pulmonary Function Data	BZC	1
Holder, Needle; Orthopedic	HXK	1
Accessories, Implant, Dental, Endosseous	NDP	1
Transducer, Ultrasonic, Diagnostic	ITX	1
Hook, Surgical, General & Plastic Surgery	GDG	1
Instruments, Surgical, Cardiovascular	DWS	1
Barrier, Absorbable, Adhesion	MCN	1
Tubes, Gastrointestinal (And Accessories)	KNT	1
Tube, Feeding	FPD	1
Bone Grafting Material, Animal Source	NPM	1
Curette, Surgical, General Use	FZS	1

Makers in Belgium

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Materialise N.V.	LEUVEN Vlaams Brabant, Belgium	28	58	0	6	api.fda.gov
Agfa N.V.	Mortsel Antwerpen, Belgium	13	31	0	7	api.fda.gov
Terumo Europe N.V.	LEUVEN Vlaams Brabant, Belgium	5	23	0	0	api.fda.gov
Barco N.V.	KORTRIJK West-Vlaanderen, Belgium	9	19	0	6	api.fda.gov
Agfa Healthcare N.V.	MORTSEL Antwerpen, Belgium	2	14	0	4	api.fda.gov
Dimequip	Frameries Hainaut, Belgium	9	13	0	0	api.fda.gov
Orfit Industries NV	WIJNEGEM Antwerpen, Belgium	16	13	0	0	api.fda.gov
Nobel Biocare c/o Medicim NV	Mechelen Antwerpen, Belgium	7	12	0	0	api.fda.gov
Ontex BV	Buggenhout Oost-Vlaanderen, Belgium	3	8	0	0	api.fda.gov
Cefaly Technology	Liege, Belgium	1	7	0	0	api.fda.gov
GC Europe N.V.	LEUVEN Vlaams Brabant, Belgium	7	7	0	0	api.fda.gov
Fcare Systems NV	Berchem Antwerpen, Belgium	2	6	0	0	api.fda.gov
Fertipro N.V.	BEERNEM West-Vlaanderen, Belgium	6	6	0	0	api.fda.gov
icometrix	Leuven Vlaams Brabant, Belgium	4	6	0	0	api.fda.gov
Gynetics Medical Products NV	Lommel Limburg, Belgium	3	5	0	0	api.fda.gov
3d-Side	Mont Saint Guibert Brabant Wallon, Belgium	7	4	0	0	api.fda.gov
DENTSPLY Implants N.V.	Hasselt Limburg, Belgium	3	4	0	0	api.fda.gov
Feops NV	Gent Oost-Vlaanderen, Belgium	2	4	0	0	api.fda.gov
Medisoft S.A.	DINANT Namur, Belgium	4	4	0	0	api.fda.gov
Bioncise NV	Wellen Limburg, Belgium	3	3	0	0	api.fda.gov
Baxter R&D Europe SRL	Braine-l'Alleud Wallonia, Belgium	5	1	2	0	api.fda.gov
Oystershellnv	Merelbeke-Melle Oost-Vlaanderen, Belgium	4	3	0	0	api.fda.gov
Agfa HealthCare	Gent West-Vlaanderen, Belgium	1	2	0	0	api.fda.gov
Baxter SA	LESSINES Hainaut, Belgium	4	1	1	0	api.fda.gov
Biocartis NV	Mechelen Antwerpen, Belgium	4	1	1	1	api.fda.gov
Clouds of Care NV	Ghent Oost-Vlaanderen, Belgium	1	2	0	0	api.fda.gov
Endo Tools Therapeutics S.A	Anderlecht Brussels-Capital Region, Belgium	1	2	0	0	api.fda.gov
Euromi S.A.	Andrimont Liege, Belgium	2	2	0	0	api.fda.gov
Fujirebio Europe N.V.	GHENT Oost-Vlaanderen, Belgium	5	1	1	0	api.fda.gov
H&O EQUIPMENTS NV/Clinic6	Ghislenghien Hainaut, Belgium	1	2	0	0	api.fda.gov
Ion Beam Applications S.A.	LOUVAIN-LA-NEUVE, BE Brabant Wallon, Belgium	1	2	0	35	api.fda.gov
Myocene	Liege, Belgium	2	2	0	0	api.fda.gov
Plastiflex Healthcare Division Of Plastiflex Group NV	Paal Beringen Limburg, Belgium	2	2	0	0	api.fda.gov
Relu BV	Leuven Antwerpen, Belgium	1	2	0	0	api.fda.gov
Sunrise SA	Namur, Belgium	1	2	0	0	api.fda.gov
DiaSource ImmunoAssays, SA	Louvain-La-Neuve Brabant Wallon, Belgium	19	1	0	0	api.fda.gov
Elemental NV	Ghent Oost-Vlaanderen, Belgium	3	1	0	0	api.fda.gov
Fluidda NV	Kontich Antwerpen, Belgium	1	1	0	0	api.fda.gov
G-Flex Europe SRL	Nivelles Brabant Wallon, Belgium	5	1	0	0	api.fda.gov
Kci Polymedics BV	PEER Limburg, Belgium	1	1	0	0	api.fda.gov
Lacar MDX Technologies	Liege, Belgium	7	1	0	0	api.fda.gov
Lifestream Pharma N.V.	Seneffe Hainaut, Belgium	1	1	0	0	api.fda.gov
Medxpress.pro	Leuven Vlaams Brabant, Belgium	2	1	0	0	api.fda.gov
Nyxoah SA	Mont-Saint-Guibert Brabant Wallon, Belgium	1	0	1	0	api.fda.gov
Nyxoah SA Milmort	Herstal Liege, Belgium	1	0	1	0	api.fda.gov
Physiol.s.a	Liege, Belgium	2	0	1	0	api.fda.gov
Qompium NV	Hasselt Limburg, Belgium	2	1	0	0	api.fda.gov
S.A. Instrumentation Difra	Eupen Liege, Belgium	6	1	0	0	api.fda.gov
Tita-Link B.V.B.A	Brussels Brussels-Capital Region, Belgium	1	1	0	0	api.fda.gov
Terumo BCT Europe N.V.	Leuven Vlaams Brabant, Belgium	2	1	0	0	api.fda.gov
Wishbone	Flemalle Liege, Belgium	1	1	0	0	api.fda.gov
Xeos Medical	Sint-Denijs-Westrem Oost-Vlaanderen, Belgium	2	1	0	0	api.fda.gov
3D Systems - Layerwise	Heverlee Vlaams Brabant, Belgium	8	0	0	0	api.fda.gov
Amnovis BV	Aarschot Flanders, Belgium	7	0	0	0	api.fda.gov
Agfa Gevaert N.V.	Mortsel Antwerpen, Belgium	1	0	0	0	api.fda.gov
Aqua free Industries BV	Lommel Limburg, Belgium	1	0	0	0	api.fda.gov
BEDAL International NV	Diepenbeek Limburg, Belgium	3	0	0	0	api.fda.gov
Binoptics SPRL	Watermaal-Bosvoorde Brussels-Capital Region, Belgium	3	0	0	0	api.fda.gov
Beldico S.A.	Marche-en-Famenne Luxembourg, Belgium	1	0	0	0	api.fda.gov
Cosmade Belgium BV	Heist-op-den-Berg Antwerpen, Belgium	2	0	0	0	api.fda.gov
Dermatoo SRL	Embourg Liege, Belgium	1	0	0	0	api.fda.gov
Diagam S.A.	Ghislenghien Hainaut, Belgium	3	0	0	0	api.fda.gov
DIAGENODE s.a.	Seraing Liege, Belgium	2	0	0	0	api.fda.gov
Devroye Instruments SRL	Etterbeek Brussels-Capital Region, Belgium	1	0	0	0	api.fda.gov
Eledricity	Merelbeke-Melle Oost-Vlaanderen, Belgium	1	0	0	0	api.fda.gov
Enestia Belgium NV (sharp Belgium)	Hamont-Achel Limburg, Belgium	1	0	0	0	api.fda.gov
Eye Specials International	MOL Antwerpen, Belgium	1	0	0	0	api.fda.gov
Handi-Move	NINOVE Oost-Vlaanderen, Belgium	2	0	0	0	api.fda.gov
Hasa Optix	Brussels Brussels-Capital Region, Belgium	21	0	0	0	api.fda.gov
Henau	KORTRIJK West-Vlaanderen, Belgium	2	0	0	0	api.fda.gov
Hoet Eyewear Design BV	Brugge Brussels-Capital Region, Belgium	2	0	0	0	api.fda.gov
Hubert De Backer N.V.	Temse Oost-Vlaanderen, Belgium	1	0	0	0	api.fda.gov
Innorehab SRL	Ottignies Brabant Wallon, Belgium	1	0	0	0	api.fda.gov
Immunodiagnostic Systems SA	Liege, Belgium	1	0	0	0	api.fda.gov
Jabbla	Gent Oost-Vlaanderen, Belgium	1	0	0	0	api.fda.gov
Lonza Verviers SRL.	Verviers Liege, Belgium	8	0	0	0	api.fda.gov
Matthieu Duchene Design	Bruxelles Brussels-Capital Region, Belgium	2	0	0	0	api.fda.gov
Medenvision	Westerlo Antwerpen, Belgium	2	0	0	0	api.fda.gov
Medi-Line S.A.	Angleur Liege, Belgium	1	0	0	0	api.fda.gov
Minze NV	Antwerpen, Belgium	1	0	0	0	api.fda.gov
Mo-Vis BV	Deinze Oost-Vlaanderen, Belgium	1	0	0	2	api.fda.gov
Moveup	Brussels Brussels-Capital Region, Belgium	1	0	0	0	api.fda.gov
Materialise Motion N.V.	Paal Limburg, Belgium	2	0	0	0	api.fda.gov
Novartis Manufacturing NV	Puurs-Sint-Amands Antwerpen, Belgium	1	0	0	0	api.fda.gov
OMC nv	Marke West-Vlaanderen, Belgium	2	0	0	0	api.fda.gov
Optimat (afdeling Huize Tordale VZW)	Lichtervelde West-Vlaanderen, Belgium	1	0	0	0	api.fda.gov
Ontex Eeklo	Eeklo Oost-Vlaanderen, Belgium	1	0	0	0	api.fda.gov
Runlite S.A.	SOUMAGNE Liege, Belgium	6	0	0	0	api.fda.gov
Spentys	Forest Brussels-Capital Region, Belgium	3	0	0	0	api.fda.gov
Surgical Instruments Belgium SA	GEMBLOUX Namur, Belgium	21	0	0	0	api.fda.gov
ScarPro NV	Aalter Flanders, Belgium	1	0	0	0	api.fda.gov
TWE Meulebeke NV	Meulebeke West-Vlaanderen, Belgium	2	0	0	0	api.fda.gov
Theo BV	ANTWERP Antwerpen, Belgium	2	0	0	0	api.fda.gov
UniWeb BV	Meise Vlaams Brabant, Belgium	1	0	0	0	api.fda.gov

Updated November 2, 2026. 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.