Updated 23 October 2026
In-vitro diagnostics distributors in Belgium: 33 licensed establishments
Belgium has 6 independent distributors in the Index so far.
The Bastion Hale Distributor Index lists 33 establishments in Belgium whose registry records include in-vitro diagnostics: 6 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.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 1Luminix HealthLangdorp45 lines0 registrationssize 24.3
- 2ImTec Diagnostics N.V.Antwerpen11 lines0 registrationssize 19.2
- 3LabconsultBrussels8 lines0 registrationssize 18.1
- 4EuroMedix POC nvLeuven5 lines0 registrationssize 18.8
- 5Laborimpex S.A.FOREST4 lines0 registrationssize 15.8
- 6DentalSolutionsEU BVKinrooi0 lines0 registrationssize 9.7
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.
- 1ROMED nvHoogstraten4 lines0 registrationssize 18.1
- 2Conmed Europe BVDrogenbos3 lines0 registrationssize 17.2
- 3Aidian Belgium BVDiegem3 lines0 registrationssize 15.0
- 4Fujirebio Europe N.V.Gent, Oost-Vlaanderen0 lines26 registrationssize 54.7
- 5Medisoft S.A.Sorinnes0 lines8 registrationssize 43.7
- 6BARCO N.V.kortrijk, WVL0 lines4 registrationssize 44.1
- 70 lines4 registrationssize 33.5
- 80 lines2 registrationssize 26.4
- 9Terumo BCT Europe N.V.Zaventem0 lines1 registrationsize 27.0
- 10Ascensia Diabetes Care Belgium NV-SADiegem (Machelen)0 lines0 registrationssize 9.7
- 11Axon Lab N.V.Diegem0 lines0 registrationssize 9.7
- 12LabCorp BVMechelen0 lines0 registrationssize 9.7
- 13Laboratoires Pharmaceutiques TrenkerThines (Nivelles)0 lines0 registrationssize 9.7
- 14DIAsource ImmunoAssays S.A.Louvain-la-Neuve0 lines26 registrationssize 50.6
- 15FERTIPRO N.V.Beernem0 lines18 registrationssize 52.4
- 16Biocartis NVMechelen0 lines7 registrationssize 39.9
- 17Diagenode S.A.Seraing0 lines5 registrationssize 36.2
- 18Sterigenics Belgium (Petit Rechain) SRLVerviers Liege0 lines1 registrationsize 42.3
- 19PALM MEDICAL INTERNATIONAL BVBuggenhout Oost-Vlaanderen0 lines1 registrationsize 35.5
- 20Pharmamed SA.Anderlecht Brussels-Capital Region0 lines1 registrationsize 27.9
See Germany: 880 independent distributors
Distributor in Belgium? Add your company, free
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 | 18 | 55% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 2 | 6% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 7 | 21% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 6 | 18% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 17 | 52% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 9 | 27% | 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 Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about in-vitro diagnostics distributors in Belgium
How many in-vitro diagnostics distributors are there in Belgium?
The Index counts 33 establishments in Belgium with in-vitro diagnostics in their registry record, of which 6 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 23 October 2026.
Who can hold an 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 an 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 see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as an 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: 24 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): 13 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.