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COGENTIX MEDICAL, INC.

USA · Orangeburg

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel — 5 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

13listed device types

Class I 2Class II 11Class III 0

plus 10 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

10 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 4IIa 4Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

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 States10 registration records, 2 510(k), 0 PMA

Manufacturer names merged into this page: COGENTIX MEDICAL, INC.

FDA 510(k) clearances by year

12018 · K181292

12026 · K253905

FDA listed device types

showing 8 of 13

Device, Cystometric, Hydraulic 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1Nasopharyngoscope (Flexible Or Rigid) 1Cystoscope And Accessories, Flexible/Rigid 1Bronchoscope (Flexible Or Rigid) 1Hysteroscope (And Accessories) 1Endoscopic Access Overtube, Gastroenterology-Urology 1Led Light Source 1

Market	Identifier	Name	Class / date
US	K253905	PrimeSight UltraView System	2026-04-07
US	K181292	PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor	2018-11-15

COGENTIX MEDICAL, 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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