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Northgate Technologies, Inc.

USA · Elgin

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

14listed device types

Class I 4Class II 10Class III 0

plus 19 registration records and 55 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 4Class III 2

11 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 2CLASS C 1

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

11active ARTG entries

Class I 1IIa 8IIb 1Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

2registrations

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 States19 registration records, 55 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: Northgate Technologies Inc. · NORTHGATE TECHNOLOGIES INC. · NORTHGATE TECHNOLOGIES, INC.

FDA 510(k) clearances by year

181991

81992

21993

31994

21995

31996

31997

21998

31999

22000

22001

12003

22004

12012

12013

22021

FDA listed device types

showing 8 of 14

Gastroscope And Accessories, Flexible/Rigid 1Insufflator, Endoscopic Vessel Harvesting 1Apparatus, Exhaust, Surgical 1Tubing, Noninvasive 1Laparoscope, General & Plastic Surgery 1Stimulator, Nerve 1Evacuator, Gastro-Urology 1Lithotriptor, Electro-Hydraulic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202813	URO-TOUCH 9 French Probe	2021-06-14
US	K202944	NEBULAE SRS Laparoscopic Surgical Smoke Removal System	2021-03-25
US	K130368	AUTOLITH TOUCH; URO TOUCH	2013-11-15
BR	81040530003	SISTEMA DE IRRIGAÇÃO FLO-ASSIST* II	Class II
BR	80978569016	Sistema Nebulae I	Class II
CA	27217	AUTOLITH ELECTRO-HYDRAULIC LITHOTRIPTER SYSTEM	Class III
CA	61870	LITHOTRIPTER, ELECTROHYDRAULIC PROBE FAMILY	Class II
CA	61990	ELECTRO - HYDRAULIC LITHOTRIPTER EXTENDER CABLE	Class II

Northgate Technologies, 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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