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Terang Nusa Snd Bhd

Malaysia · Kota Bharu

✓ 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

4listed device types

Class I 4Class II 0Class III 0

plus 13 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 9Class II 9

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

1active device licences

Class II 1

11 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 States13 registration records, 27 510(k), 0 PMA

Brazil18 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: TERANG NUSA (MALAYSIA) SDN. BHD. · TERANG NUSA (MALAYSIA) SDN BHD · Terang Nusa · TERANG NUSA SDN BHD

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170779	Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein	2017-05-24
US	K161932	Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink	2016-11-28
US	K153510	Powder Free Polychloroprene Examination Glove Green	2016-03-21
BR	80495510131	MEDIX BRASIL LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO DE NITRILO SEM PÓ	Class I
BR	10341529003	Luva Cirúrgica Estéril Cirurgic Powder Free	Class II
BR	10341529004	Luva Cirúrgica Estéril New Hand Texturizada	Class II
CA	98426	FINESSIS PERSONAL LATEX, POWDER FREE SURGICAL GLOVES	Class II

Terang Nusa Snd Bhd

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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