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Smith & Nephew Medical (Shanghai) Limited

✓ Record-verifiedregistrations found in 12 marketsUnified social credit code 91310000607411498D

This company holds 1 NMPA certificates in China and has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 11 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

1China registrations

Class II 1

as of 2026-09-04

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

214listed device types

Class I 112Class II 97Class III 1unclassified 4

plus 1,830 registration records and 815 510(k), 167 PMA

UKUnited KingdomMHRA PARD

867registered device records

Class I 387Class IIa 253Class IIb 114Class III 106Custom-made - Class I 1Custom-made - Class IIa 4System or Procedure Pack 2

BRBrazilANVISA

182registered devices

Class I 104Class II 78

502 including historic records

SASaudi ArabiaSFDA

17registered imported devices

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

CACanadaMDALL

251active device licences

Class II 118Class III 130Class IV 3

445 including historic records

TWTaiwanTFDA

109valid device licences

Class I 48Class II 61

SGSingaporeHSA SMDR

152device registrations

CLASS B 44CLASS C 96CLASS D 12

KRSouth KoreaMFDS GMP

16GMP quality-system certificates

Import 16

AUAustraliaTGA ARTG

418active ARTG entries

Class I 134Class III 133IIa 94IIb 44Class Im (measuring) 3Class Is (sterile) 10

HKHong KongMDACS

83valid listings

Class II 15Class III 49Class IV 19

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.

European Union6 raw hits, 6 excluded, 0 confirmed

United States1,830 registration records, 815 510(k), 167 PMA

China1 certificates (Class III 0 / II 1 / I 0), as of 2026-09-04

United Kingdom867 confirmed, 0 excluded

Brazil182 confirmed, 0 excluded

Saudi Arabia17 confirmed, 0 excluded

Canada251 confirmed, 0 excluded

Manufacturer names merged into this page: Smith & Nephew, Inc. · SMITH & NEPHEW, INC. · Smith & Nephew Medical Ltd · SMITH & NEPHEW INC. · SMITH & NEPHEW WOUND MANAGEMENT (LA JOLLA) · SMITH & NEPHEW MEDICAL LTD.

Regulatory identity

UK responsible person: T.J.Smith and Nephew,Limited
Unified social credit code: 91310000607411498D
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1999-12-03
Registered capital: USD 16,200,000
Paid-in capital: USD 16,200,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Last approval date: 2026-07-17

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

242007

272008

282009

272010

282011

262012

192013

112014

192015

172016

212017

152018

152019

142020

142021

182022

172023

162024

92025

42026

FDA listed device types

showing 8 of 214

Chisel, Surgical, Manual 1Solvent, Adhesive Tape 1Beads, Hydrophilic, For Wound Exudate Absorption 1Stripper, Surgical 1Broach 1Phantom, Anthropomorphic, Radiographic 1Tamp 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	沪械注准20212060428	4K内窥镜摄像系统	Class II
UK	34864	CUTIPLAST (Non-Sterile)	Class I
UK	34864	APPLICA IV100	Class I
UK	34864	HANSAPOR Steril (Hull)	Class I
US	K261968	Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)	2026-07-09
US	DEN250037	TESSA Spatial Surgery System; INTELLIO Tablet (72205455)	2026-07-06
US	K260646	RENASYS EDGE (66803126)	2026-05-27
BR	80804050211	Instrumental Não Articulado Não Cortante SNO	Class I
BR	80804050205	Instrumental para Ortopedia Não Articulado Cortante	Class I
BR	80804050333	FIXADORES EXTERNOS SMART TSF	Class I
SA	ME0000004264SFDAA00002	90 DEGREE High Profile Hinge	—
SA	ME0000004264SFDAA00004	Russian Wire Fixation Bolt	—
CA	223	DERMAGRAFT	Class IV
CA	253	TRANSCYTE	Class IV
CA	1389	PANSEMENT ELASTOPLAST AVEC TIGES DESINFECTANTES IODINE BUD	Class II