Updated 22 October 2026
In-vitro diagnostics distributors in Belgium: 32 licensed establishments
The Bastion Hale Distributor Index lists 32 establishments in Belgium whose registry records include in-vitro diagnostics: 18 with a channel role (importer, distributor, wholesaler or authorised representative), 4 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 EUDAMED, US FDA (openFDA), web and Health Canada, last seen on 23 October 2026.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 17 | 53% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 3% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 7 | 22% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 6 | 19% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 17 | 53% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 9 | 28% | 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 20 in-vitro diagnostics 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 | Fujirebio Europe N.V. Gent | Channel Importer, Distributor, Authorised representative, Registration holder, Manufacturer, Exporter | In-vitro diagnostics | 7 | 5 | 0 | 40.6 | 4/5 |
| 2 | 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 |
| 3 | 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 |
| 4 | Luminix Health Langdorp | Channel Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics | 0 | 0 | 46 | 27.8 | 4/5 |
| 5 | Terumo BCT Europe N.V. Zaventem | Channel Importer, Authorised representative, Manufacturer, Exporter | In-vitro diagnostics | 2 | 1 | 0 | 27.0 | 4/5 |
| 6 | LaCAR MDx Technologies Liège | Channel Importer, Manufacturer | In-vitro diagnostics | 4 | 1 | 0 | 26.7 | 4/5 |
| 7 | ImTec Diagnostics N.V. Antwerpen | Channel Importer | General hospital and consumables, In-vitro diagnostics, Orthopaedics, spine and trauma | 0 | 0 | 13 | 23.1 | 4/5 |
| 8 | Laborimpex S.A. FOREST | Channel Importer | General hospital and consumables, In-vitro diagnostics, Surgery and endoscopy | 0 | 0 | 13 | 23.1 | 4/5 |
| 9 | ROMED nv Hoogstraten | Channel Importer, Authorised representative | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +6 more | 0 | 0 | 6 | 22.8 | 4/5 |
| 10 | Immunodiagnostic Systems SA Liege | Channel Authorised representative, Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 22.1 | 4/5 |
| 11 | Labconsult Brussels | Channel Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics | 0 | 0 | 8 | 21.4 | 4/5 |
| 12 | Conmed Europe BV Drogenbos | Channel Importer, Authorised representative | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology +3 more | 0 | 0 | 3 | 20.6 | 4/5 |
| 13 | Aidian Belgium BV Diegem | Channel Importer | Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 0 | 0 | 5 | 19.9 | 4/5 |
| 14 | Axon Lab N.V. Diegem | Channel Importer | In-vitro diagnostics | 0 | 0 | 4 | 19.2 | 4/5 |
| 15 | DentalSolutionsEU BV Kinrooi | Channel Importer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, General hospital and consumables +5 more | 0 | 0 | 2 | 17.3 | 4/5 |
| 16 | Ascensia Diabetes Care Belgium NV-SA Diegem (Machelen) | Channel Importer | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 1 | 15.7 | 4/5 |
| 17 | LabCorp BV Mechelen | Channel Importer | In-vitro diagnostics | 0 | 0 | 0 | 13.1 | 3/5 |
| 18 | Laboratoires Pharmaceutiques Trenker Thines (Nivelles) | Channel Importer | Anaesthesia and respiratory, In-vitro diagnostics | 0 | 0 | 0 | 13.1 | 3/5 |
| 19 | FERTIPRO N.V. Beernem | Holder Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 41 | 12 | 0 | 48.8 | 4/5 |
| 20 | DIAsource ImmunoAssays S.A. Louvain-la-Neuve | Holder Registration holder, Manufacturer | In-vitro diagnostics | 19 | 6 | 0 | 42.1 | 4/5 |
Questions about in-vitro diagnostics distributors in Belgium
How many in-vitro diagnostics distributors are there in Belgium?
The Index counts 32 establishments in Belgium with in-vitro diagnostics in their registry record, of which 18 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from EUDAMED, US FDA (openFDA), web and Health Canada and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics 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 in-vitro diagnostics 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 ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a in-vitro diagnostics 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 in-vitro diagnostics 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
In-vitro diagnostics in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 23 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 20 establishments, last seen 22 October 2026. US government work, public domain.
- web (public register): 12 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 6 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.