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Qube Medical Products Sdn Bhd

www.qubemedic.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN MY-MF-000022842

This company has registrations in European Union, United States, Brazil, Australia — 4 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 300

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

USUnited StatesFDA openFDA

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

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 Union342 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States2 registration records, 2 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: QUBE MEDICAL PRODUCTS SDN BHD · QUBE MEDICAL PRODUCTS SDN

Regulatory identity

EU manufacturer SRN: MY-MF-000022842
EU authorised representative: Qube Integrated Europe GmbH
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
EU	09551028345747	POPPY	Class I
EU	09551028345730	POPPY	Class I
EU	09551028345723	POPPY	Class I
EU	09551028345860	POPPY	Class I
US	K153732	Powder Free Blue Nitrile Examination Glove	2016-07-29
US	K123537	POWDER FREE LATEX EXAMINATION GLOVES	2014-02-12
BR	10160610094	LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO	Class I

Qube Medical Products 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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