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TCOAG IRELAND LIMITED

Ireland · Bray

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel, Russia — 6 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

15listed device types

Class I 3Class II 12Class III 0

plus 31 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

24registered devices

Class I 3Class II 21

33 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

46active device licences

Class II 38Class III 8

64 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IVD Class 1 1IVD Class 2 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

10active registrations

Class 1 7Class 2a 3

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 States31 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil24 confirmed, 0 excluded

Canada46 confirmed, 0 excluded

Manufacturer names merged into this page: TCOAG IRELAND LIMITED · TCOAG IRELAND LTD

FDA listed device types

showing 8 of 15

Reagent, Russel Viper Venom 1General Purpose Reagent 1Multi-Analyte Controls Unassayed 1Antithrombin Iii Quantitation 1System, Fibrinogen Determination 1Test, Qualitative And Quantitative Factor Deficiency 1System, Multipurpose For In Vitro Coagulation Studies 1Plasma, Coagulation Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81457600073	RISTOCETIN	Class II
BR	81457600057	TriniCLOT Owrens Buffer	Class I
BR	81457600059	INSTRUMENTO DE HEMOSTASIA - DT 100	Class II
CA	11384	COAG-A-MATE COAGULATION INSTRUMENTS	Class II
CA	12855	AUTO APTT REAGENT	Class III
CA	12857	VERIFY CONTROL PLASMAS FOR PROTIME & PTT TIMES	Class III

TCOAG IRELAND LIMITED

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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