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MARDX DIAGNOSTICS INC., A TRINITY BIOTECH COMPANY

USA · Carlsbad

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

8510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 8Class III 1

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 States0 registration records, 8 510(k), 0 PMA, 1 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: MARDX DIAGNOSTICS INC., A TRINITY BIOTECH COMPANY

Registration details (sample)

Market	Identifier	Name	Class / date
US	K964787	MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM	1997-04-08
US	K951709	MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM	1996-06-07
US	K950829	MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM	1996-06-05
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

MARDX DIAGNOSTICS INC., A TRINITY BIOTECH COMPANY

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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