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: 5 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 13 manufacturers' own import or sales entities, 0 regulatory representatives, and 14 manufacturers or exporters, out of 695 medical device establishments in Belgium overall. The records come from EUDAMED, US FDA (openFDA), MHRA UK 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 5 independent in-vitro diagnostics distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Luminix Health Langdorp | Distributor Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics | 0 | 0 | 45 | 24.3 | 4/5 |
| 2 | ImTec Diagnostics N.V. Antwerpen | Distributor Importer | General hospital and consumables, In-vitro diagnostics, Orthopaedics, spine and trauma | 0 | 0 | 11 | 19.2 | 4/5 |
| 3 | Labconsult Brussels | Distributor Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics | 0 | 0 | 8 | 18.1 | 4/5 |
| 4 | Laborimpex S.A. FOREST | Distributor Importer | General hospital and consumables, In-vitro diagnostics, Surgery and endoscopy | 0 | 0 | 4 | 15.8 | 4/5 |
| 5 | DentalSolutionsEU BV Kinrooi | Distributor Importer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, General hospital and consumables +5 more | 0 | 0 | 0 | 9.7 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (27)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | ROMED nv Hoogstraten | Maker's own entity Importer, Authorised representative | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +6 more | 0 | 0 | 4 | 18.1 | 4/5 |
| 2 | Conmed Europe BV Drogenbos | Maker's own entity Importer, Authorised representative | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology +3 more | 0 | 0 | 3 | 17.2 | 4/5 |
| 3 | Aidian Belgium BV Diegem | Maker's own entity Importer | Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 0 | 0 | 3 | 15.0 | 4/5 |
| 4 | Fujirebio Europe N.V. Gent, Oost-Vlaanderen | Maker's own entity Importer, Distributor, Authorised representative, Registration holder, Manufacturer, Exporter | In-vitro diagnostics | 21 | 26 | 0 | 54.7 | 4/5 |
| 5 | Medisoft S.A. Sorinnes | Maker's own entity Importer, Authorised representative, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, In-vitro diagnostics | 6 | 8 | 0 | 43.7 | 4/5 |
| 6 | BARCO N.V. kortrijk, WVL | Maker's own entity Importer, Authorised representative, Manufacturer, Exporter | Cardiovascular, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +2 more | 22 | 4 | 0 | 44.1 | 4/5 |
| 7 | LACAR MDX Technologies S.A. Liège | Maker's own entity Importer, Manufacturer | In-vitro diagnostics | 4 | 4 | 0 | 33.5 | 4/5 |
| 8 | Immunodiagnostic Systems S.A. Liege | Maker's own entity Authorised representative, Manufacturer | In-vitro diagnostics | 1 | 2 | 0 | 26.4 | 4/5 |
| 9 | Terumo BCT Europe N.V. Zaventem | Maker's own entity Importer, Authorised representative, Manufacturer, Exporter | In-vitro diagnostics | 2 | 1 | 0 | 27.0 | 4/5 |
| 10 | Ascensia Diabetes Care Belgium NV-SA Diegem (Machelen) | Maker's own entity Importer | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 0 | 9.7 | 3/5 |
| 11 | Axon Lab N.V. Diegem | Maker's own entity Importer | In-vitro diagnostics | 0 | 0 | 0 | 9.7 | 3/5 |
| 12 | LabCorp BV Mechelen | Maker's own entity Importer | In-vitro diagnostics | 0 | 0 | 0 | 9.7 | 3/5 |
| 13 | Laboratoires Pharmaceutiques Trenker Thines (Nivelles) | Maker's own entity Importer | Anaesthesia and respiratory, In-vitro diagnostics | 0 | 0 | 0 | 9.7 | 3/5 |
| 14 | DIAsource ImmunoAssays S.A. Louvain-la-Neuve | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 20 | 26 | 0 | 50.6 | 4/5 |
| 15 | FERTIPRO N.V. Beernem | Manufacturer Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 41 | 18 | 0 | 52.4 | 4/5 |
| 16 | Biocartis NV Mechelen | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 7 | 7 | 0 | 39.9 | 4/5 |
| 17 | Diagenode S.A. Seraing | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 4 | 5 | 0 | 36.2 | 3/5 |
| 18 | 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 |
| 19 | 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 |
| 20 | Pharmamed SA. Anderlecht Brussels-Capital Region | Manufacturer Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +3 more | 18 | 1 | 0 | 27.9 | 3/5 |
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 5 are independent distributors (a channel role and no manufacturing of their own). The number comes from EUDAMED, US FDA (openFDA), MHRA UK 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 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 10 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 6 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 12 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
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.