Updated 22 October 2026
In-vitro diagnostics distributors in Ireland: 31 licensed establishments
The Bastion Hale Distributor Index lists 31 establishments in Ireland whose registry records include in-vitro diagnostics: 16 with a channel role (importer, distributor, wholesaler or authorised representative), 5 registration holders without a channel role, and 10 registered as manufacturer or exporter only, out of 627 medical device establishments in Ireland overall. The records come from US FDA (openFDA), EUDAMED, 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 | 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.
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 | BECKMAN COULTER IRELAND, INC. Clare | Channel Authorised representative, Registration holder, Manufacturer | In-vitro diagnostics | 107 | 27 | 0 | 58.8 | 4/5 |
| 2 | TRINITY BIOTECH, PLC Bray, Co. Wicklow, WK | Channel Importer, Registration holder, Manufacturer | In-vitro diagnostics | 14 | 6 | 0 | 42.2 | 4/5 |
| 3 | Abbott Ireland Sligo | Channel Authorised representative, Manufacturer | Ear, nose and throat, In-vitro diagnostics | 31 | 1 | 0 | 36.2 | 3/5 |
| 4 | Dexcom International Limited Athenry, Galway, Galway | Channel Importer, Distributor, Exporter | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology | 3 | 2 | 0 | 33.4 | 4/5 |
| 5 | Siemens Healthcare Diagnostics Manufacturing Limited Dublin | Channel Authorised representative, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology | 14 | 1 | 0 | 32.3 | 4/5 |
| 6 | Randox Teoranta Co. Donegal | Channel Distributor, Authorised representative, Manufacturer | In-vitro diagnostics | 6 | 1 | 0 | 30.1 | 4/5 |
| 7 | Waters Technologies (Ireland) Ltd. Wexford | Channel Authorised representative, Manufacturer | In-vitro diagnostics | 5 | 1 | 0 | 27.7 | 4/5 |
| 8 | TRULIFE LTD. Dublin 24 | Channel Importer, Authorised representative, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology, Surgery and endoscopy | 3 | 1 | 0 | 27.2 | 4/5 |
| 9 | Connect Medical Supplies Ltd Dublin | Channel Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics | 0 | 0 | 7 | 21.0 | 4/5 |
| 10 | CS Life Sciences Europe Ltd Dublin | Channel Importer, Authorised representative | Cardiovascular, General hospital and consumables, In-vitro diagnostics +2 more | 0 | 0 | 3 | 20.6 | 4/5 |
| 11 | Vectura Ireland Limited NEWTOWNMOUNTKENNEDY | Channel Importer, Authorised representative | Anaesthesia and respiratory, General hospital and consumables, In-vitro diagnostics +2 more | 0 | 0 | 3 | 20.6 | 4/5 |
| 12 | Delcath Systems Ltd Galway | Channel Importer, Authorised representative | Anaesthesia and respiratory, Cardiovascular, Gastroenterology, urology and OB/GYN +4 more | 0 | 0 | 1 | 18.0 | 4/5 |
| 13 | Ascensia Diabetes Care Ireland Limited Dublin 2 | Channel Importer | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 1 | 15.7 | 4/5 |
| 14 | ARKRAY Ireland Limited Dublin | Channel Importer, Authorised representative | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 0 | 15.3 | 3/5 |
| 15 | Sotas Europe Limited Dublin | Channel Importer, Authorised representative | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 0 | 15.3 | 3/5 |
| 16 | Creative Supply Chain DAC, a Biotouch Company Shannon, Co, Clare | Channel Importer | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology +2 more | 0 | 0 | 0 | 13.1 | 3/5 |
| 17 | Abbott Ireland, Diagnostics Division Sligo, LF | Holder Registration holder, Manufacturer | Ear, nose and throat, In-vitro diagnostics | 323 | 108 | 0 | 69.1 | 4/5 |
| 18 | Techno-path Manufacturing Ltd. Co. Tipperary, TP | Holder Registration holder, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics | 46 | 16 | 0 | 52.2 | 4/5 |
| 19 | DEPUY (IRELAND) CO. CORK Munster, CK | Holder Registration holder, Manufacturer | In-vitro diagnostics, Orthopaedics, spine and trauma, Surgery and endoscopy | 138 | 7 | 0 | 50.1 | 3/5 |
| 20 | TCOAG IRELAND LIMITED Co. Wicklow, WK | Holder Registration holder, Manufacturer | In-vitro diagnostics | 31 | 4 | 0 | 42.9 | 4/5 |
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 16 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED, web and Health Canada and was last refreshed on 22 October 2026.
Who can hold a 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 a 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 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 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.
- web (public register): 9 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.
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.