HomeUnited Kingdom of Great Britain and Northern IrelandSMITHS MEDICAL LTD.

SMITHS MEDICAL LTD.

United Kingdom of Great Britain and Northern Ireland · Hythe Kent
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia — 7 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
109510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 109 510(k), 24 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
177registered devices
Class I 27Class II 150
195 including historic records
SASaudi ArabiaSFDA
16registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
99active device licences
Class II 77Class III 22
133 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
8active ARTG entries
Class I 2IIa 4IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States0 registration records, 109 510(k), 24 PMA, 1 excluded
Brazil177 confirmed, 2 excluded
Saudi Arabia16 confirmed, 0 excluded
Canada99 confirmed, 0 excluded
Manufacturer names merged into this page: SMITHS MEDICAL INTERNATIONAL LIMITED · SMITHS MEDICAL INTERNATIONAL LTD. · SMITHS MEDICAL ASD INC. · SMITHS MEDICAL ASD, INC. · SMITHS MEDICAL ASD, INC · SMITHS MEDICAL ASD, INC. (MINNEAPOLIS)

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Hythe Kent

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
SMITHS MEDICAL GROUP LTD
Company number
16241901
Registration status
Active
Legal form
Private Limited Company
Incorporated
2025-02-10
Principal activity
98000 - Residents property management
Registered address
794 HIGH STREET, KINGSWINFORD, DY6 8BQ

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

21997
11998
72004
62005
72006
142007
102008
122009
32010
12011
42012
32013
12014
12016
52017
82018
12019
12020
22021
12024

Registration details (sample)

MarketIdentifierNameClass / date
USK232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe2024-05-31
USK210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula2021-11-26
USK211634Hypodermic Needle-Pro EDGE Safety Device2021-08-26
BR10150470076ESTILETE INTRODUTOR PARA SONDAS ENDOTRAQUEAIS PORTEXClass II
BR10150470005CANULA DE GUEDELL PORTEXClass II
BR10150470006CANULA PARA TRAQUEOSTOMIA PORTEXClass II
SAME0000005837SFDAA00001Portex Venn Reusable Tracheal Tube Introducer
SAME0000005837SFDAA00002Portex Tracheal Tube Exchange Guide
CA12848GRASEBY 9000 SERIES - AMBULATORY INFUSION PUMPClass III
CA66746OPTIVA PERIPHERAL INTRAVASCULAR CATHETERSClass II
CA66745JELCO 2 INTRAVASCULAR CATHETERSClass II

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