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Home›Malaysia›GALLANT QUALITY SDN. BHD.

GALLANT QUALITY SDN. BHD.

Malaysia · Taiping Perak
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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 11 registration records and 5 510(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
0active device licences
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 States11 registration records, 5 510(k), 0 PMA
Manufacturer names merged into this page: GALLANT QUALITY SDN. BHD.
Same-named companies — This database also contains companies with near-identical names: Quality Gallant Sdn. Bhd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Malaysia
City
Taiping Perak

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

22007 · K071322
12008 · K081592
12010 · K092874
12015 · K151528

FDA listed device types

Polymer Patient Examination Glove 1Medical Glove, Specialty 1Latex Patient Examination Glove 1Fentanyl And Other Opioid Protection Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK151528Powder Free Nitrile (Black) Examination Gloves2015-10-09
USK092874POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES2010-06-22
USK081592POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES2008-12-03

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