Updated 22 October 2026
In-vitro diagnostics distributors in the United Kingdom: 113 licensed establishments
The Bastion Hale Distributor Index lists 113 establishments in the United Kingdom whose registry records include in-vitro diagnostics: 2 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 26 manufacturers' own import or sales entities, 6 regulatory representatives, and 79 manufacturers or exporters, out of 6,118 medical device establishments in the United Kingdom overall. The records come from 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 |
|---|---|---|---|
| Distributor | 5 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 30 | 27% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 27 | 24% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 98 | 87% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 17 | 15% | 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 the United Kingdom
In Great Britain a manufacturer based outside the UK registers its devices with the MHRA through a UK Responsible Person. The UKRP can be an independent firm or the distributor; which one you pick decides who controls the registration if the relationship ends.
Top 2 independent in-vitro diagnostics distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
Only 2 independent distributors are registered for this segment here; the rest are manufacturers or their own sales entities.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | CELLPATH LTD NEWTOWN Powys, Powys | Distributor Distributor, Authorised representative, Manufacturer | In-vitro diagnostics, Surgery and endoscopy | 30 | 40 | 9 | 60.6 | 4/5 |
| 2 | HERE WE FLO LTD LONDON London, City of | Distributor Distributor | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 9 | 1 | 0 | 24.6 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (111)
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 | HAAG-STREIT UK LTD. Bishop's Stortford Hertfordshire, Hertfordshire | Maker's own entity Authorised representative, Registration holder, Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, In-vitro diagnostics +2 more | 9 | 21 | 8 | 55.2 | 4/5 |
| 2 | Fujifilm Healthcare UK Limited Bedford | Maker's own entity Authorised representative | In-vitro diagnostics | 57 | 15 | 14 | 53.6 | 4/5 |
| 3 | Ortho-Clinical Diagnostics Pencoed Bridgend | Maker's own entity Authorised representative, Registration holder, Manufacturer | Ear, nose and throat, In-vitro diagnostics | 101 | 84 | 5 | 70.6 | 4/5 |
| 4 | MILLIPORE (U.K.) LTD. LIVINGSTON, W. LOTHIAN West Lothian, SL | Maker's own entity Authorised representative, Registration holder, Manufacturer | In-vitro diagnostics | 15 | 22 | 5 | 55.0 | 4/5 |
| 5 | Corin Limited CIRENCESTER Gloucestershire, Gloucestershire | Maker's own entity Authorised representative, Manufacturer, Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +4 more | 88 | 21 | 3 | 59.5 | 4/5 |
| 6 | IMMUNODIAGNOSTIC SYSTEMS LIMITED Boldon Colliery Durham, TW | Maker's own entity Authorised representative, Registration holder, Manufacturer | Cardiovascular, In-vitro diagnostics | 123 | 97 | 4 | 71.5 | 4/5 |
| 7 | GBUK GROUP LIMITED Selby North Yorkshire, N. Yorks | Maker's own entity Authorised representative, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN +3 more | 43 | 46 | 2 | 58.4 | 4/5 |
| 8 | BIO-DIAGNOSTICS LTD. WORCESTERSHIRE, Worcestershire | Maker's own entity Authorised representative, Manufacturer | In-vitro diagnostics | 38 | 41 | 2 | 55.7 | 4/5 |
| 9 | ALBA BIOSCIENCE LIMITED PENICUIK Midlothian | Maker's own entity Authorised representative, Registration holder, Manufacturer | In-vitro diagnostics | 62 | 38 | 2 | 61.8 | 4/5 |
| 10 | DiaSorin Italia S.p.A. UK Branch Dartford Kent | Maker's own entity Authorised representative, Manufacturer | In-vitro diagnostics | 15 | 22 | 5 | 51.0 | 4/5 |
| 11 | Draeger Medical UK Ltd hemel hempstead, Hertfordshire | Maker's own entity Authorised representative, Manufacturer | In-vitro diagnostics | 0 | 6 | 5 | 27.9 | 4/5 |
| 12 | QIAGEN Manchester Ltd. Manchester Lancashire | Maker's own entity Authorised representative, Manufacturer | In-vitro diagnostics | 2 | 5 | 4 | 35.5 | 4/5 |
| 13 | PLANER Limited SUNBURY, MIDDLESEX England, Middlesex | Maker's own entity Authorised representative, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 2 | 4 | 2 | 32.7 | 4/5 |
| 14 | OXOID LIMITED BASINGSTOKE, HAMPSHIRE, HA | Maker's own entity Authorised representative, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, In-vitro diagnostics | 125 | 146 | 2 | 72.8 | 4/5 |
| 15 | MAST GROUP LTD. BOOTLE, MERSEYSIDE Liverpool | Maker's own entity Authorised representative, Manufacturer | In-vitro diagnostics | 68 | 11 | 1 | 51.1 | 4/5 |
| 16 | Revvity Limited Pontyclun Wales, Wales | Maker's own entity Authorised representative, Manufacturer | In-vitro diagnostics | 25 | 6 | 4 | 47.1 | 4/5 |
| 17 | SOUTHERN SCIENTIFIC LTD Henfield West Sussex, WS | Maker's own entity Authorised representative, Registration holder, Manufacturer | In-vitro diagnostics, Imaging, radiology and radiotherapy | 3 | 5 | 1 | 37.5 | 4/5 |
| 18 | Merit Medical UK Limited Earley Reading, Berkshire | Maker's own entity Authorised representative, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 266 | 4 | 3 | 58.1 | 4/5 |
| 19 | LifeScan Scotland Limited INVERNESS Highland, Inverness-Shire | Maker's own entity Authorised representative, Manufacturer | General hospital and consumables, In-vitro diagnostics, Surgery and endoscopy | 12 | 4 | 2 | 40.1 | 4/5 |
| 20 | SPD DEVELOPMENT COMPANY LIMITED Bedford, Bedfordshire | Maker's own entity Authorised representative, Manufacturer | In-vitro diagnostics | 10 | 2 | 1 | 35.3 | 4/5 |
Questions about in-vitro diagnostics distributors in the United Kingdom
How many in-vitro diagnostics distributors are there in the United Kingdom?
The Index counts 113 establishments in the United Kingdom with in-vitro diagnostics in their registry record, of which 2 are independent distributors (a channel role and no manufacturing of their own). The number comes from 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 the United Kingdom?
In Great Britain a manufacturer based outside the UK registers its devices with the MHRA through a UK Responsible Person. The UKRP can be an independent firm or the distributor; which one you pick decides who controls the registration if the relationship ends.
How do I find a in-vitro diagnostics distributor in the United Kingdom?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and the United Kingdom 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 the United Kingdom?
A company that appears in a public regulatory registry with an address in the United Kingdom 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 the United Kingdom
In-vitro diagnostics in other Other markets markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 100 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 70 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 28 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.