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Trinity Biotech, Inc.

Ireland · Bray

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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

54listed device types

Class I 17Class II 36Class III 0unclassified 1

plus 88 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

33registered devices

Class I 11Class II 22

41 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

185active device licences

Class II 148Class III 36Class IV 1

249 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IVD Class 1 1IVD Class 2 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

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 States88 registration records, 25 510(k), 0 PMA, 12 excluded

Brazil33 confirmed, 1 excluded

Canada185 confirmed, 1 excluded

Manufacturer names merged into this page: TRINITY BIOTECH, PLC · Trinity Biotech (Primus Corporation dba Trinity Biotech) · Trinity Biotech USA · Trinity Biotech do Brasil · MARDX DIAGNOSTICS INC., A TRINITY BIOTECH COMPANY · TRINITY BIOTECH PLC

FDA 510(k) clearances by year

11997

31999

22000

12001

12002

72003

22004

12009

12011

22013

12014

22017

12023

FDA listed device types

showing 8 of 54

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)

Market	Identifier	Name	Class / date
US	K222635	Premier Resolution System	2023-08-04
US	K172254	Lyme B. burgdorferi (IgM) MarStripe Test	2017-10-23
US	K163095	Lyme B. burgdorferi (IgG) MarStripe Test	2017-02-01
BR	81733730017	Reagente Premier Tampão B	Class I
BR	81733730018	Reagente Premier Wash	Class I
BR	81733730019	Reagente Premier Tampão A	Class I
CA	8915	BARTELS CYTOTOXICITY ASSAY CLOSTRIDIUM DIFFICILE TOXINS	Class III
CA	36626	ANTINUCLEAR ANTIBODY TEST SYSTEM HEP-2	Class II
CA	36854	B. BURGDORFERI (IGM) MARBLOT STRIP TEST SYSTEM	Class II

Trinity Biotech, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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