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AAMEDIX GLOVE SDN BHD

Malaysia · Shah Alam · aamedix-glove.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN MY-MF-000025086

This company has registrations in European Union, United States, Saudi Arabia — 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

8UDI-DI device records

Class I 5Class IIa 3

USUnited StatesFDA openFDA

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered 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.

European Union8 raw hits, 0 excluded, 8 confirmed

United States1 registration records, 1 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: AAMEDIX GLOVE SDN BHD · AAMedix Glove Sdn Bhd

Regulatory identity

EU manufacturer SRN: MY-MF-000025086
EU authorised representative: CMC Medical Devices & Drugs SL

Registration details (sample)

Market	Identifier	Name	Class / date
EU	09551015252188	AAMEDIX Nitrile Powder Free Blue Examination Gloves	Class I
EU	09551015252171	AAMEDIX Nitrile Powder Free Blue Examination Gloves	Class I
EU	09551015252164	AAMEDIX Nitrile Powder Free Blue Examination Gloves	Class I
EU	19551015255803	AAMEDIX LATEX STERILE POWDERED SURGICAL GLOVES, THERMOFORM BI-FOLD	Class IIa
US	K220121	Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black	2022-04-11
SA	ME0000003979SFDAA00011	RUBBER DENTAL DAM	—

AAMEDIX GLOVE 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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