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BRIGHTWAY HOLDINGS SDN. BHD.

Malaysia · Klang

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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 30 registration records and 24 510(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

4active device licences

Class II 4

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

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 States30 registration records, 24 510(k), 0 PMA, 1 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: BRIGHTWAY HOLDINGS SDN. BHD. · BRIGHTWAY HOLDINGS SDN BHD

Registration details (sample)

Market	Identifier	Name	Class / date
US	K211816	Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	2022-11-02
US	K170686	Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs	2017-07-14
US	K162294	BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS	2017-04-21
CA	105107	PURPLE NITRILE-XTRA POWDER FREE EXAM GLOVES	Class II
CA	105108	PURPLE NITRILE POWDER FREE EXAM GLOVES	Class II
CA	105109	STERLING NITRILE POWDER FREE EXAM GLOVES	Class II

BRIGHTWAY HOLDINGS SDN. 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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