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MONITEX INDUSTRIAL CO., LTD.

Taiwan · San-Chung City Taipei

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 6Class II 1Class III 0

plus 14 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

2registered 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 States14 registration records, 9 510(k), 0 PMA

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: MONITEX INDUSTRIAL CO., LTD. · Monitex Industrial Co.,Ltd

FDA 510(k) clearances by year

12005

12006

12008

12009

12014

12015

12016

22017

FDA listed device types

Activator, Ultraviolet, For Polymerization 1Syringe, Irrigating (Non Dental) 1Amalgamator, Dental, Ac-Powered 1Syringe, Restorative And Impression Material 1Material, Impression Tray, Resin 1Mixer, Cement, For Clinical Use 1Heat Source For Bleaching Teeth 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K161855	LED Curing Light	2017-11-27
US	K152192	LED Curing Light	2017-04-07
US	K153078	LED Curing Light GT-2000	2016-06-28
SA	ME0000006399SFDAA00002	MONITEX	—
SA	ME0000006399SFDAA00001	MONITEX	—

MONITEX INDUSTRIAL CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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