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DIROS TECHNOLOGY, INC.

Canada · Markham

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 8 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

5listed device types

Class I 0Class II 5Class III 0

plus 12 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

31registered devices

Class I 2Class II 29

39 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

8 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIb 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States12 registration records, 8 510(k), 0 PMA

Brazil31 confirmed, 0 excluded

Manufacturer names merged into this page: DIROS TECHNOLOGY, INC. · DIROS TECHNOLOGY INC · DIROS TECHNOLOGY, INC

FDA 510(k) clearances by year

12002

12006

12010

22011

12014

12015

12017

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Probe, Radiofrequency Lesion 1Cable, Electrode 1Electrode, Depth 1Generator, Lesion, Radiofrequency 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170708	OWL RF INSULATED CANNULAE	2017-06-27
US	K150371	Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH	2015-07-30
US	K141586	OWL CANNULAE	2014-12-30
BR	80859840183	SONDA PARA LESÃO - TASKER	Class II
BR	80859840175	ELETRODO PARA LESÃO TASKER	Class II
BR	80859840187	MICRO ELETRODO PARA CORDOTOMIA	Class II

DIROS TECHNOLOGY, INC.

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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