HomeMalaysiaTERANG NUSA (MALAYSIA) SDN. BHD.

TERANG NUSA (MALAYSIA) SDN. BHD.

Malaysia · Kota Bharu
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, 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
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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
Same-named companies — This database also contains companies with near-identical names: Terang Nusa Sdn Bhd, Terang Nusa Snd Bhd. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Malaysia
City
Kota Bharu

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11989
41999
42000
22001
22004
42005
12009
22010
12011
12014
22015
22016
12017

FDA listed device types

Polymer Patient Examination Glove 1Surgeon'S Gloves 1Medical Glove, Specialty 1Latex Patient Examination Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein2017-05-24
USK161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink2016-11-28
USK153510Powder Free Polychloroprene Examination Glove Green2016-03-21
BR80495510131MEDIX BRASIL LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO DE NITRILO SEM PÓClass I
BR10341529003Luva Cirúrgica Estéril Cirurgic Powder FreeClass II
BR10341529004Luva Cirúrgica Estéril New Hand TexturizadaClass II
CA98426FINESSIS PERSONAL LATEX, POWDER FREE SURGICAL GLOVESClass II

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