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Hartalega Sdn. Bhd

✓ 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, Australia, Hong Kong, 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

5listed device types

Class I 5Class II 0Class III 0

plus 62 registration records and 61 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class I 8Class IIa 2

BRBrazilANVISA

27registered devices

Class I 25Class II 2

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

SASaudi ArabiaSFDA

11registered imported devices

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

CACanadaMDALL

8active device licences

Class II 8

12 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIa 2Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 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.

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

United States62 registration records, 61 510(k), 0 PMA, 5 excluded

United Kingdom10 confirmed, 0 excluded

Brazil27 confirmed, 4 excluded

Saudi Arabia11 confirmed, 2 excluded

Canada8 confirmed, 1 excluded

Manufacturer names merged into this page: HARTALEGA SDN BHD · HARTALEGA SDN. BHD. · Hartalega Sdn. Bhd · Hartalega Sdn Bhd · Hartalega 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 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

31996

41997

21998

41999

32000

12002

12004

62005

32006

12007

12009

12011

12012

32013

42014

22015

32016

62017

52018

32020

FDA listed device types

Surgeon'S Gloves 1Fentanyl And Other Opioid Protection Glove 1Polymer 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	K201748	Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs	2020-10-02
US	K201531	Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)	2020-08-05
US	K200897	Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)	2020-06-01
BR	10201230137	LUVA DE NITRILO PARA PROCEDIMENTO NÃO ESTÉRIL ( SEM PÓ)	Class I
BR	10330660283	LUVA NITRÍLICA SEM PÓ DESCARPACK III	Class I
BR	80495510057	LUVA ANTIMICROBIANA MEDIX BRASIL	Class I
SA	ME0000004998SFDAA00001	GloveOn Protect	—
SA	ME0000004998SFDAA00002	GloveOn Edge	—
CA	104017	ACCELERATOR FREE NITRILE POWDER FREE EXAMINATION GLOVES	Class II
CA	68521	LATEX MEDICAL EXAMINATION GLOVES	Class II
CA	92363	STERILE NITRILE EXAMINATION GLOVE	Class II