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Hartalega NGC Sdn Bhd

Malaysia · Kuala Lumpur · www.hartalega.com.my

✓ Record-verifiedregistrations found in 11 marketsEU SRN MY-MF-000010459

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class I 268Class IIa 32

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

7listed device types

Class I 7Class II 0Class III 0

plus 148 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class I 8Class IIa 2

BRBrazilANVISA

10registered devices

Class I 10

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

4registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

23 including historic records

TWTaiwanTFDA

8valid device licences

Class I 8

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIa 2Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 5

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 Union800 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States148 registration records, 31 510(k), 0 PMA

United Kingdom10 confirmed, 0 excluded

Brazil10 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Manufacturer names merged into this page: HARTALEGA NGC SDN BHD · HARTALEGA NGC SDN. BHD. (LOT 39496) · HARTALEGA NGC SDN. BHD. · HARTALRGA NGC SDN BHD · Hartalega NGC Sdn.Bhd · Hartalega NGC Sdn. Bhd.

Regulatory identity

EU manufacturer SRN: MY-MF-000010459
EU authorised representative: MDSS GmbH
UK responsible person: MDSS-UK RP LIMITED
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

FDA 510(k) clearances by year

22014

52015

12016

42017

42019

42020

12021

32022

12023

32025

32026

FDA listed device types

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

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08594202840653	ILICO ACF	Class I
EU	08594202840646	ILICO ACF	Class I
EU	08594202840639	ILICO ACF	Class I
EU	08594202840622	ILICO ACF	Class I
UK	47172	AMBIFLEX LATEX POWDER FREE	Class I
UK	47173	Latex Examination Glove	Class I
UK	47178	Latex Surgical Gloves	Class IIa
US	K260558	Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	2026-07-28
US	K254285	Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue	2026-07-20
US	K260867	Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)	2026-06-17
BR	80495510057	LUVA ANTIMICROBIANA MEDIX BRASIL	Class I
BR	80495510019	MEDIX BRASIL AMG	Class I
BR	80495510032	MEDIX BRASIL LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO DE NITRILO SEM PÓ PA	Class I
SA	ME0000013068SFDAA00001	Gloveon Lexie	—
SA	ME0000009125SFDAA00001	GloveOn Celeste	—