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Koon Seng Sdn Bhd

Malaysia · Petaling Jaya · www.koonseng.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN MY-MF-000024234

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada — 5 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

4UDI-DI device records

Class I 4

USUnited StatesFDA openFDA

5listed device types

Class I 5Class II 0Class III 0

plus 11 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class I 2

BRBrazilANVISA

1registered devices

Class I 1

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

3 including historic records

TWTaiwanTFDA

0valid device licences

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.

European Union4 raw hits, 0 excluded, 4 confirmed

United States11 registration records, 7 510(k), 0 PMA

United Kingdom2 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: KOON SENG SDN BHD

Regulatory identity

EU manufacturer SRN: MY-MF-000024234
EU authorised representative: Obelis s.a.
UK responsible person: Obelis UK Ltd

FDA 510(k) clearances by year

11989 · K891821

22001 · K013537

12009 · K093375

12011 · K110960

12018 · K171171

12021 · K212613

FDA listed device types

Fentanyl And Other Opioid Protection Glove 1Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Latex Patient Examination Glove 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04023368112174	Domotherm	Class I
EU	04023368112129	Domotherm	Class I
EU	04023368112112	Domotherm	Class I
EU	04023368112150	Domotherm	Class I
UK	47172	Royal Imperial Latex	Class I
UK	56286	Royal Imperial Nitrile	Class I
US	K212613	Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)	2021-12-21
US	K171171	KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)	2018-02-22
US	K110960	ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE	2011-07-14
BR	80495510004	TOP QUALITY - LUVAS DE LÁTEX PARA PROCEDIMENTO NÃO CIRÚRGICO, COM PÓ -	Class I

Koon Seng Sdn Bhd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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