Updated 23 October 2026
In-vitro diagnostics distributors in Ireland: 31 licensed establishments
Ireland has 1 independent distributor in the Index so far.
The Bastion Hale Distributor Index lists 31 establishments in Ireland whose registry records include in-vitro diagnostics: 1 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 15 manufacturers' own import or sales entities, 0 regulatory representatives, and 15 manufacturers or exporters, out of 637 medical device establishments in Ireland overall. The records come from US FDA (openFDA), EUDAMED, 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.
- 11 line0 registrationssize 14.6
Include manufacturers, their own sales entities and regulatory representatives (30)
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.
- 16 lines0 registrationssize 17.1
- 2Vectura Ireland LimitedNEWTOWNMOUNTKENNEDY1 line0 registrationssize 14.6
- 3BECKMAN COULTER IRELAND, INC.Clare, Co. Clare0 lines36 registrationssize 62.0
- 4TRINITY BIOTECH, PLCBray, Co. Wicklow, WK0 lines8 registrationssize 45.3
- 5Abbott IrelandSligo0 lines2 registrationssize 40.5
- 6Dexcom International LimitedAthenry, Galway, Galway0 lines2 registrationssize 31.5
- 70 lines1 registrationsize 32.3
- 8Randox TeorantaCo. Donegal0 lines1 registrationsize 30.1
- 9Trulife LimitedDublin 240 lines1 registrationsize 29.6
- 100 lines1 registrationsize 27.7
- 11ARKRAY Ireland LimitedDublin0 lines0 registrationssize 11.9
- 12Delcath Systems LtdGalway0 lines0 registrationssize 11.9
- 13Sotas Europe LimitedDublin0 lines0 registrationssize 11.9
- 140 lines0 registrationssize 9.7
- 15Creative Supply Chain DAC, a Biotouch CompanyShannon, Co, Clare0 lines0 registrationssize 9.7
- 16Abbott Ireland, Diagnostics DivisionSligo, LF0 lines187 registrationssize 73.6
- 17Techno-path Manufacturing Ltd.Co. Tipperary, TP0 lines19 registrationssize 54.8
- 18DEPUY (IRELAND)CO. CORK Munster, CK0 lines13 registrationssize 55.2
- 19Merck Millipore Ltd.Co. Cork, CK0 lines7 registrationssize 43.8
- 20TCOAG IRELAND LIMITEDCo. Wicklow, WK0 lines5 registrationssize 45.6
See Germany: 888 independent distributors
Distributor in Ireland? 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 | 11 | 35% | 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 | 11 | 35% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 7 | 23% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 20 | 65% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 5 | 16% | 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 Ireland
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 Ireland
How many in-vitro diagnostics distributors are there in Ireland?
The Index counts 31 establishments in Ireland with in-vitro diagnostics in their registry record, of which 1 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada and was last refreshed on 23 October 2026.
Who can hold an in-vitro diagnostics device registration in Ireland?
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 Ireland?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Ireland 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 Ireland?
A company that appears in a public regulatory registry with an address in Ireland 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 Ireland
In-vitro diagnostics in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 23 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 21 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- 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: 8 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 9 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.