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Trinity Biotech do Brasil

Brazil · Extrema Minas Gerais

✓ 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

14listed device types

Class I 4Class II 10Class III 0

plus 16 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

26registered devices

Class I 11Class II 15

32 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

72active device licences

Class II 56Class III 16

77 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 States16 registration records, 12 510(k), 0 PMA, 17 excluded

Brazil26 confirmed, 3 excluded

Canada72 confirmed, 6 excluded

Manufacturer names merged into this page: TRINITY BIOTECH, PLC · Trinity Biotech do Brasil · TRINITY BIOTECH PLC · TRINITY BIOTECH · TRINITY BIOTECH DO BRASIL COMERCIO E IMPORTACAO LTDA · Trinity Biotech Plc.

Same-named companies — This database also contains companies with near-identical names: TRINITY BIOTECH DO BRASIL COMERCIO E IMPORTACAO LTDA. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11997

21999

12000

12001

12002

12003

12009

22013

22017

FDA listed device types

showing 8 of 14

Abnormal Hemoglobin Quantitation 1Radioassay, Angiotensin Converting Enzyme 1Calibrator, Secondary 1Solution, Stabilized Enzyme 1Radioimmunoassay, Cholyglycine, Bile Acids 1Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot 1Test, Platelet Antibody 1Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172254	Lyme B. burgdorferi (IgM) MarStripe Test	2017-10-23
US	K163095	Lyme B. burgdorferi (IgG) MarStripe Test	2017-02-01
US	K120001	UNIGOLD GIARDIA	2013-03-01
BR	81733730017	Reagente Premier Tampão B	Class I
BR	81733730018	Reagente Premier Wash	Class I
BR	81733730019	Reagente Premier Tampão A	Class I
CA	8571	BARTELS FLUORESCENT ANTINUCLEAR ANTIBODY TEST	Class II
CA	11850	BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY	Class II
CA	13291	BARTELS CHLAMYDIA IMMUNOPEROXIDASE TEST	Class III

Trinity Biotech do Brasil

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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