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Endoscopy Division

USA · Andover

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

9510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

56registered devices

Class I 26Class II 30

104 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

51device registrations

CLASS B 16CLASS C 28CLASS D 7

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

118active ARTG entries

Class I 64Class III 13IIa 30IIb 7Class Im (measuring) 1Class Is (sterile) 3

HKHong KongMDACS

17valid listings

Class II 2Class III 10Class IV 5

ILIsraelAMAR

15registrations

RURussiaRoszdravnadzor

13active registrations

Class 1 3Class 2a 6Class 2b 2Class 3 2

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 States0 registration records, 9 510(k), 0 PMA, 63 excluded

Brazil56 confirmed, 26 excluded

Saudi Arabia1 confirmed, 4 excluded

Canada0 confirmed, 7 excluded

Manufacturer names merged into this page: SMITH & NEPHEW ENDOSCOPY DIVISION · SMITH & NEPHEW INC., ENDOSCOPY DIVISION (ANDOVER) · SMITH & NEPHEW, INC - ENDOSCOPY DIVISION · Smith & Nephew, Inc. - Endoscopy Division · SMITH & NEPHEW INC.- ENDOSCOPY DIVISION · SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121904	GYNECOLOGY STERILIZATION TRAY	2013-03-11
US	K102982	ENDOBUTTON DIRECT	2011-01-05
US	K082215	OSTEORAPTOR SUTURE ANCHOR	2008-11-03
BR	80804050378	Instrumentais HEALICOIL	Class I
BR	80804059010	SISTEMA INTEGRADO LENS 4K	Class II
BR	80804059008	NOVOCUT - Orientador de Sutura	Class II
SA	ME0000015308SFDAA00001	Light Guides Cables	—

Endoscopy Division

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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