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Us Endoscopy

USA · Mentor

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Israel — 6 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

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 2Class II 8

11 including historic records

SASaudi ArabiaSFDA

10registered imported devices

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

CACanadaMDALL

28active device licences

Class II 26Class III 2

69 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

14device registrations

CLASS B 14

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States1 registration records, 3 510(k), 0 PMA, 61 excluded

Brazil10 confirmed, 33 excluded

Saudi Arabia10 confirmed, 4 excluded

Canada28 confirmed, 7 excluded

Manufacturer names merged into this page: SG ENDOSCOPY PTE LTD · UNITED STATES ENDOSCOPY GROUP INC., ALSO TRADING AS US ENDOSCOPY · United States Endoscopy Group, Inc. (US Endoscopy) · UNITED STATES ENDOSCOPY GROUP, INC. Also trading as US Endoscopy

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243894	F88 URE-SD/RD Flexible Ureteroscope	2025-05-02
US	K192518	Reusable Monopolar Active Cord	2019-10-25
US	K180731	Ultramatrix EUS Balloon	2018-04-19
BR	10259750019	Alça com Rede para Coleta de Corpos Estranhos ou Espécimes Roth Neth	Class II
BR	10259750018	CATA PÓLIPOS	Class II
BR	10259750020	Pinça guiada por fio Histoguide	Class II
SA	ME0000013866SFDAA00019	Vasto bite block	—
SA	ME0000013866SFDAA00004	BioGuard® air/water cleaning adapter – Olympus	—
CA	64824	DISPOSABLE NAKAO SNARE	Class II
CA	64820	DISPOSABLE HOT BIOPSY FORCEPS	Class II
CA	64822	REUSABLE BIOPSY FORCEPS	Class II

Us Endoscopy

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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