Updated 22 October 2026
In-vitro diagnostics distributors in the United Kingdom: 103 licensed establishments
The Bastion Hale Distributor Index lists 103 establishments in the United Kingdom whose registry records include in-vitro diagnostics: 5 with a channel role (importer, distributor, wholesaler or authorised representative), 25 registration holders without a channel role, and 73 registered as manufacturer or exporter only, out of 641 medical device establishments in the United Kingdom overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 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 | 5% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 27 | 26% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 97 | 94% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 17 | 17% | 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 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 | CYTOCELL LIMITED CAMBRIDGE Cambridgeshire, CA | Channel Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 185 | 7 | 0 | 53.2 | 3/5 |
| 2 | Owen Mumford Limited WOODSTOCK, OXFORDSHIRE, OX | Channel Distributor, Registration holder, Manufacturer | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +3 more | 34 | 10 | 0 | 46.2 | 3/5 |
| 3 | FBGC LIMITED Bridlington East Riding of Yorkshire, Yorkshire | Channel Distributor, Manufacturer | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +3 more | 15 | 2 | 0 | 34.6 | 3/5 |
| 4 | CELLPATH LTD NEWTOWN Powys | Channel Distributor, Manufacturer | In-vitro diagnostics, Surgery and endoscopy | 15 | 1 | 0 | 29.2 | 3/5 |
| 5 | HERE WE FLO LTD LONDON London, City of | Channel Distributor | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 9 | 1 | 0 | 24.6 | 3/5 |
| 6 | LEICA BIOSYSTEMS NEWCASTLE LTD. NEWCASTLE UPON TYNE, TW | Holder Registration holder, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology | 436 | 293 | 0 | 71.1 | 3/5 |
| 7 | FLEXICARE MEDICAL LTD. RHONDDA CYNON TAFF Wales | Holder Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 339 | 57 | 0 | 64.0 | 3/5 |
| 8 | RANDOX LABORATORIES LIMITED CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, AT | Holder Registration holder, Manufacturer | In-vitro diagnostics | 228 | 47 | 0 | 61.1 | 3/5 |
| 9 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED LLANBERIS Wales, GY | Holder Registration holder, Manufacturer | Cardiovascular, In-vitro diagnostics | 225 | 20 | 0 | 57.1 | 3/5 |
| 10 | OXOID LIMITED BASINGSTOKE, HAMPSHIRE, HA | Holder Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, In-vitro diagnostics | 120 | 19 | 0 | 55.4 | 3/5 |
| 11 | Ortho-Clinical Diagnostics Pencoed Bridgend | Holder Registration holder, Manufacturer | Ear, nose and throat, In-vitro diagnostics | 101 | 16 | 0 | 52.1 | 3/5 |
| 12 | ALBA BIOSCIENCE LIMITED PENICUIK Midlothian | Holder Registration holder, Manufacturer | In-vitro diagnostics | 62 | 27 | 0 | 52.0 | 3/5 |
| 13 | IMMUNODIAGNOSTIC SYSTEMS LIMITED Boldon Colliery Durham, TW | Holder Registration holder, Manufacturer | Cardiovascular, In-vitro diagnostics | 123 | 12 | 0 | 51.8 | 3/5 |
| 14 | THE BINDING SITE GROUP LIMITED BIRMINGHAM | Holder Registration holder, Manufacturer | General hospital and consumables, In-vitro diagnostics | 157 | 8 | 0 | 51.3 | 3/5 |
| 15 | PURPLE SURGICAL INTERNATIONAL LIMITED Herts England, HT | Holder Registration holder, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN +2 more | 62 | 19 | 0 | 50.4 | 3/5 |
| 16 | REMEL EUROPE LIMITED DARTFORD, KENT | Holder Registration holder, Manufacturer | In-vitro diagnostics | 150 | 6 | 0 | 49.9 | 3/5 |
| 17 | TREK DIAGNOSTIC SYSTEMS, LTD. East Grinstead West Sussex, WS | Holder Registration holder, Manufacturer, Exporter | In-vitro diagnostics | 84 | 2 | 0 | 44.6 | 3/5 |
| 18 | AXIS-SHIELD DIAGNOSTICS LIMITED DUNDEE Scotland, SL | Holder Registration holder, Manufacturer | In-vitro diagnostics | 27 | 7 | 0 | 42.0 | 3/5 |
| 19 | ABBOTT DIABETES CARE LIMITED WITNEY OXON Oxfordshire, OX | Holder Registration holder, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology | 23 | 8 | 0 | 41.8 | 3/5 |
| 20 | SPACELABS HEALTHCARE LTD. (HERTFORD) Hertford, HT | Holder Registration holder, Manufacturer | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology | 31 | 10 | 0 | 40.8 | 3/5 |
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 103 establishments in the United Kingdom with in-vitro diagnostics in their registry record, of which 5 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) 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 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 28 establishments, last seen 22 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.