HomeUnited Kingdom of Great Britain and Northern IrelandTRINITY BIOTECH (UK) LTD

TRINITY BIOTECH (UK) LTD

United Kingdom of Great Britain and Northern Ireland · Cambridge
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
51listed device types
Class I 16Class II 34Class III 0unclassified 1
plus 82 registration records and 23 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class II 10
11 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
148active device licences
Class II 116Class III 31Class IV 1
166 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States82 registration records, 23 510(k), 0 PMA, 16 excluded
Brazil10 confirmed, 3 excluded
Canada148 confirmed, 4 excluded
Manufacturer names merged into this page: TRINITY BIOTECH, PLC · Trinity Biotech USA · TRINITY BIOTECH PLC · TRINITY BIOTECH USA · TRINITY BIOTECH (UK) LTD · TRINITY BIOTECH
Same-named companies — This database also contains companies with near-identical names: Trinity Biotech USA. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Cambridge

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
TRINITY BIOTECH (UK) LIMITED
Company number
08606499
Registration status
Active
Legal form
Private Limited Company
Incorporated
2013-07-11
Principal activity
86900 - Other human health activities
Registered address
MILLS & REEVE LLP BOTANIC HOUSE, CAMBRIDGE, CB2 1PH

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11997
31999
22000
12001
12002
72003
22004
12009
22013
12014
22017

FDA listed device types

showing 8 of 51
Calibrator, Secondary 1Reagent, Borrelia Serological Reagent 1Calibrator, Primary 1System, Test, Rheumatoid Factor 1Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative 1Plasmodium Spp. Detection Reagents 1Whole Blood Hemoglobin Determination 1Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 1

Registration details (sample)

MarketIdentifierNameClass / date
USK172254Lyme B. burgdorferi (IgM) MarStripe Test2017-10-23
USK163095Lyme B. burgdorferi (IgG) MarStripe Test2017-02-01
USK140455CAPTIA MEASLES IGM2014-05-22
BR80944340001PREMIER HB9210 ANALISADOR DE HEMOGLOBINASClass II
BR80944340013ANALISADOR PREMIER RESOLUTIONClass II
BR80944340003HEMOGLOBINA A1c CALIBRADORESClass II
CA8571BARTELS FLUORESCENT ANTINUCLEAR ANTIBODY TESTClass II
CA11850BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAYClass II
CA13291BARTELS CHLAMYDIA IMMUNOPEROXIDASE TESTClass III

Similar companies

2BScientific Ltd.
United Kingdom of Great Britain and Northern Ireland · markets 0
AbBaltis Ltd
United Kingdom of Great Britain and Northern Ireland · markets 0
Advanced Molecular Diagnostics Ltd.
United Kingdom of Great Britain and Northern Ireland · markets 3
Air Moving Products Ltd Trading as Steady Moto
United Kingdom of Great Britain and Northern Ireland · markets 0
Albert Waeschle Ltd
United Kingdom of Great Britain and Northern Ireland · markets 3
Alerta Medical Ltd.
United Kingdom of Great Britain and Northern Ireland · markets 5
Is this your company? Claim the page, add information or report a data error.Claim / report an error →