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Sti Medical Sdn Bhd

Malaysia · Selangor

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, 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

pendingnot queried

USUnited StatesFDA openFDA

7510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 16Class II 1

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.

United States0 registration records, 7 510(k), 0 PMA, 32 excluded

Brazil17 confirmed, 37 excluded

Saudi Arabia1 confirmed, 52 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: ZIMED Medical San. ve Tic. Ltd. Sti · Gözükara Medical Ltd. Sti · PROMA MEDICAL LTD.STI (SHRODER)

Registration details (sample)

Market	Identifier	Name	Class / date
US	K102949	COLONOSCOPY ASSISTANT	2011-06-15
US	K110147	ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE	2011-04-08
US	K090324	ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY	2010-12-20
BR	80519830016	Kit Instrumental para Fixador Externo ZIMED	Class I
BR	81207910069	Barras FC para Fixação Externa ZIMED	Class I
BR	81207910070	Barras TAV para Fixação Externa ZIMED	Class I
SA	ME0000011664SFDAA00001	Electronic ENT Chair	—

Sti Medical Sdn Bhd

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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