Updated 22 October 2026
Medical device distributors in Belgium: 690 licensed establishments
The Bastion Hale Distributor Index lists 690 medical device establishments registered with an address in Belgium: 365 with a channel role (importer, distributor, wholesaler or authorised representative), 11 registration holders without a channel role, and 314 registered as manufacturer or exporter only. The records come from EUDAMED, US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
By segment
| Segment | Establishments | |
|---|---|---|
| Surgery and endoscopy | 29 | Search in the Index |
| Orthopaedics, spine and trauma | 16 | Search in the Index |
| Cardiovascular | 12 | Search in the Index |
| Ear, nose and throat | 10 | Search in the Index |
| Gastroenterology, urology and OB/GYN | 21 | Search in the Index |
| Dental | 11 | Search in the Index |
| Anaesthesia and respiratory | 9 | Search in the Index |
| Patient monitoring and neurology | 20 | Search in the Index |
| Ophthalmic | 15 | Search in the Index |
| In-vitro diagnostics | 20 | Search in the Index |
| General hospital and consumables | 28 | Search in the Index |
| Aesthetics, dermatology and lasers | 3 | Search in the Index |
| Imaging, radiology and radiotherapy | 19 | Search in the Index |
| No segment in the registry record | 581 |
Segments come from the device listings linked to each establishment, so one company can appear in several rows. Imaging and radiology are shown because the registries contain them; Bastion Hale's launch services do not cover them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 326 | 47% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 4 | 1% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 75 | 11% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 20 | 3% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 379 | 55% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 27 | 4% | 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.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later; the Audit covers it per market.
Top 20 establishments by size
Channel roles (importer, distributor, wholesaler, authorised representative) are listed first, then registration holders, then manufacturers. Size is a 0 to 100 score built from products listed, registrations held, roles, sources and principals represented. Complete is 0 to 5 for website, address, segments, principals and counts.
| # | 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 | TERUMO EUROPE N.V. Leuven | Channel Importer, Authorised representative, Registration holder, Manufacturer, Exporter | General hospital and consumables | 23 | 8 | 0 | 48.1 | 3/5 |
| 3 | Fujirebio Europe N.V. Gent | Channel Importer, Distributor, Authorised representative, Registration holder, Manufacturer, Exporter | In-vitro diagnostics | 7 | 5 | 0 | 40.6 | 4/5 |
| 4 | Medisoft S.A. Sorinnes | Channel Importer, Authorised representative, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, In-vitro diagnostics | 6 | 6 | 0 | 40.6 | 4/5 |
| 5 | Orfit Industries N.V. Wijnegem | Channel Distributor, Manufacturer | Ear, nose and throat, Patient monitoring and neurology, Orthopaedics, spine and trauma +2 more | 29 | 2 | 0 | 40.1 | 4/5 |
| 6 | 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 |
| 7 | PhysIOL s.a. Liège | Channel Importer, Registration holder, Manufacturer | No segment in record | 7 | 6 | 0 | 36.6 | 3/5 |
| 8 | Alcon Laboratories Belgium Puurs-Sint-Amands | Channel Importer, Authorised representative, Exporter | Ophthalmic | 20 | 1 | 0 | 35.6 | 4/5 |
| 9 | ONTEX BV Buggenhout | Channel Importer, Manufacturer, Exporter | Gastroenterology, urology and OB/GYN | 10 | 1 | 0 | 32.3 | 4/5 |
| 10 | GC Europe N.V. Leuven | Channel Importer, Manufacturer | Dental | 10 | 1 | 0 | 30.7 | 4/5 |
| 11 | F CARE SYSTEMS NV Berchem | Channel Importer, Registration holder, Manufacturer | No segment in record | 5 | 1 | 0 | 29.3 | 3/5 |
| 12 | G-Flex Europe SRL Nivelles | Channel Importer, Manufacturer | Gastroenterology, urology and OB/GYN | 5 | 1 | 0 | 27.7 | 4/5 |
| 13 | BINOPTICS SPRL Watermael-Boitsfort | Channel Distributor, Manufacturer, Exporter | Ophthalmic | 3 | 1 | 0 | 27.2 | 4/5 |
| 14 | Terumo BCT Europe N.V. Zaventem | Channel Importer, Authorised representative, Manufacturer, Exporter | In-vitro diagnostics | 2 | 1 | 0 | 27.0 | 4/5 |
| 15 | LaCAR MDx Technologies Liège | Channel Importer, Manufacturer | In-vitro diagnostics | 4 | 1 | 0 | 26.7 | 4/5 |
| 16 | MedEnvision bv Westerlo | Channel Importer, Manufacturer, Exporter | Surgery and endoscopy | 2 | 1 | 0 | 25.8 | 3/5 |
| 17 | Handi-Move NV Ninove | Channel Importer, Manufacturer | General hospital and consumables | 2 | 1 | 0 | 24.2 | 4/5 |
| 18 | OMC NV Marke | Channel Importer, Manufacturer | General hospital and consumables | 2 | 1 | 0 | 24.2 | 4/5 |
| 19 | MedXPress.Pro Leuven | Channel Importer, Manufacturer | Imaging, radiology and radiotherapy, Surgery and endoscopy | 2 | 1 | 0 | 24.2 | 3/5 |
| 20 | Novartis Manufacturing NV Puurs-Sint-Amands | Channel Importer, Manufacturer | Ophthalmic | 2 | 1 | 0 | 24.2 | 3/5 |
Questions about medical device distributors in Belgium
How many medical device distributors are there in Belgium?
The Index counts 690 medical device establishments registered in Belgium, of which 365 hold a channel role as importer, distributor, wholesaler or authorised representative. The rest are registration holders or manufacturers. The number comes from EUDAMED, US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a medical 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 medical device distributor in Belgium?
Start with the segment table on this page, open the top establishments and check their roles, principals and registration counts. Then search the Index for your device and Belgium to see the counts for your segment and 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 distributor in Belgium?
An establishment is a company that appears in a public regulatory registry with an address in Belgium, in any of the roles importer, distributor, wholesaler, authorised representative, sponsor, registration holder, manufacturer or exporter. Each company is counted once per country even if it holds several licences or appears in several registries. No contacts or named individuals are collected.
Segment pages for Belgium
Related markets in EU and EEA
Sources
- EUDAMED economic operator registration, European Commission public API: 646 establishments, last seen 22 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 109 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 25 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.