HomeUnited Kingdom of Great Britain and Northern IrelandSMITHS MEDICAL INTERNATIONAL LIMITED

SMITHS MEDICAL INTERNATIONAL LIMITED

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

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 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
8510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
21registered devices
Class II 21
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
29active device licences
Class II 27Class III 2
36 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
22active ARTG entries
Class I 1IIa 14IIb 4Class Is (sterile) 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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, 8 510(k), 0 PMA, 6 excluded
Brazil21 confirmed, 10 excluded
Saudi Arabia2 confirmed, 3 excluded
Canada29 confirmed, 5 excluded
Manufacturer names merged into this page: SMITHS MEDICAL INTERNATIONAL LIMITED · SMITHS MEDICAL INTERNATIONAL LTD. · SMITHS MEDICAL INTERNATIONAL LTD · SMITHS MEDICAL INTERNACIONAL LTD · SMITHS HEALTHCARE MANUFACTURING SA DE CV -MÉXICO PARA SMITHS MEDICAL INTERNATIONAL LTD. · Smiths Medical International Limited
Same-named companies — This database also contains companies with near-identical names: SMITHS MEDICAL INTERNACIONAL LTD. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Ashford

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 GROUP INTERNATIONAL HOLDINGS LIMITED
Company number
01085153
Registration status
Active
Legal form
Private Limited Company
Incorporated
1972-12-05
Principal activity
70100 - Activities of head offices
Registered address
LEVEL 10, LONDON, SE1 9AX

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

12004 · K041348
32005 · K051322
12006 · K060945
12007 · K071527
12013 · K123957
12019 · K181660

Registration details (sample)

MarketIdentifierNameClass / date
USK181660Acapella Choice Blue Vibratory PEP Device2019-10-24
USK123957PNEUPAC PARAPAC PLUS2013-09-16
USK071527PNEUPAC VR1 AIR MIX2007-10-04
BR10150470072CONECTOR 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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