Updated 22 October 2026
Cardiovascular device distributors in Belgium: 12 licensed establishments
The Bastion Hale Distributor Index lists 12 establishments in Belgium whose registry records include cardiovascular: 2 with a channel role (importer, distributor, wholesaler or authorised representative), 0 registration holders without a channel role, and 10 registered as manufacturer or exporter only, out of 690 medical device establishments in Belgium overall. The records come from US FDA (openFDA), EUDAMED and Health Canada, last seen on 22 October 2026.
Cardiovascular covers stents, catheters, pacemakers, heart valves, ECG and vascular access. Most products are implantable or high risk, which concentrates the segment in fewer, better capitalised importers. Reimbursement rules shape who can sell here more than in any other segment.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 2 | 17% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 2 | 17% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 1 | 8% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 9 | 75% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 5 | 42% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Belgium
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
Top 12 cardiovascular establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | MATERIALISE N.V. Leuven | Channel Importer, Authorised representative, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 100 | 14 | 0 | 56.7 | 4/5 |
| 2 | BARCO N.V. kortrijk | Channel Importer, Authorised representative, Manufacturer, Exporter | Cardiovascular, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +2 more | 22 | 1 | 0 | 37.3 | 4/5 |
| 3 | Sterigenics Belgium (Petit Rechain) SRL Verviers Liege | Manufacturer Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +9 more | 329 | 1 | 0 | 42.3 | 3/5 |
| 4 | PALM MEDICAL INTERNATIONAL BV Buggenhout Oost-Vlaanderen | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 85 | 1 | 0 | 35.5 | 3/5 |
| 5 | SURGICAL INSTRUMENTS BELGIUM SA Gembloux | Manufacturer Manufacturer | Cardiovascular, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology +2 more | 21 | 1 | 0 | 32.0 | 4/5 |
| 6 | GMED Healthcare BVBA ( a Johnson & Johnson Company) Courcelles Luxembourg | Manufacturer Exporter | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +2 more | 32 | 1 | 0 | 30.7 | 3/5 |
| 7 | Sterigenics Belgium (Fleurus) SRL Fleurus Hainaut | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Dental +6 more | 28 | 1 | 0 | 30.0 | 3/5 |
| 8 | FEops NV Gent | Manufacturer Manufacturer | Cardiovascular, Imaging, radiology and radiotherapy | 4 | 2 | 0 | 28.8 | 4/5 |
| 9 | Dimequip Frameries Hainaut | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +1 more | 14 | 1 | 0 | 26.7 | 3/5 |
| 10 | St. Jude Medical Coordination Center BVBA European Distribution Center BruCargo Vlaams Brabant | Manufacturer Manufacturer, Exporter | Cardiovascular, Ear, nose and throat, In-vitro diagnostics +2 more | 8 | 1 | 0 | 26.3 | 3/5 |
| 11 | Bard European Distribution Center NV Olen Antwerpen | Manufacturer Exporter | Cardiovascular, Ear, nose and throat, Gastroenterology, urology and OB/GYN +1 more | 12 | 1 | 0 | 25.9 | 3/5 |
| 12 | Qompium nv Hasselt | Manufacturer Manufacturer | Cardiovascular | 1 | 1 | 0 | 19.8 | 4/5 |
Questions about cardiovascular distributors in Belgium
How many cardiovascular distributors are there in Belgium?
The Index counts 12 establishments in Belgium with cardiovascular in their registry record, of which 2 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED and Health Canada and was last refreshed on 22 October 2026.
Who can hold a cardiovascular device registration in Belgium?
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
How do I find a cardiovascular distributor in Belgium?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Belgium to reveal three profiles. For a shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a cardiovascular distributor in Belgium?
A company that appears in a public regulatory registry with an address in Belgium and whose linked device listings fall in the cardiovascular segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Belgium
Cardiovascular in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 12 establishments, last seen 22 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 5 establishments, last seen 22 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 2 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.