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Given Imaging , Ltd.

Israel · Mansfield

✓ 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

8listed device types

Class I 1Class II 7Class III 0

plus 15 registration records and 33 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

7active device licences

Class II 7

30 including historic records

TWTaiwanTFDA

9valid device licences

Class I 3Class II 6

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

IIa 14

HKHong KongMDACS

4valid listings

Class II 4

ILIsraelAMAR

15registrations

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 States15 registration records, 33 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: Given Imaging Vietnam Co., Ltd. · GIVEN IMAGING LTD. · GIVEN IMAGING, INC. · SIERRA SCIENTIFIC INSTRUMENTS LLC, A GIVEN IMAGING COMPANY · GIVEN IMAGIN, INC.

FDA 510(k) clearances by year

12001

22002

32003

32004

12005

32006

22007

22009

22010

32011

12013

22014

22016

22017

12018

12021

12023

12024

FDA listed device types

System, Imaging, Gastrointestinal, Wireless, Capsule 1Oximeter 1Oximeter, Ear 1Gastrointestinal Motility System, Capsule 1System, Gastrointestinal Motility (Electrical) 1Colon Capsule Imaging System 1System, Imaging, Esophageal, Wireless, Capsule 1Electrode, Ph, Stomach 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240276	PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software	2024-05-10
US	K230991	PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E	2023-06-30
US	K211684	PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E	2021-08-27
BR	10349000436	CÁPSULA PILLCAM PATENCY	Class II
BR	10349000438	SISTEMA BRAVO DE MONITORAMENTO DE PH	Class II
BR	10349000445	ENDOSCOPIA POR CÁPSULA PILLCAM	Class II
CA	61553	MICRO TRANSDUCER CATHETERS	Class II
CA	78077	ACCUTRAC PH SYSTEM	Class II
CA	84202	ACCUFET PH DISPOSABLE PH CATHETERS	Class II

Given Imaging , 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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