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Smiths Medical Asd, Inc.

USA · Keene

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

53510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 53 510(k), 18 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

153registered devices

Class I 26Class II 127

171 including historic records

SASaudi ArabiaSFDA

14registered imported devices

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

CACanadaMDALL

51active device licences

Class II 38Class III 13

75 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

35device registrations

CLASS B 21CLASS C 13CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

137active ARTG entries

Class I 36Class III 1IIa 66IIb 28Class Is (sterile) 6

HKHong KongMDACS

2valid listings

Class III 1Class IV 1

ILIsraelAMAR

26registrations

RURussiaRoszdravnadzor

13active registrations

Class 1 3Class 2a 8Class 2b 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, 53 510(k), 18 PMA

Brazil153 confirmed, 0 excluded

Saudi Arabia14 confirmed, 0 excluded

Canada51 confirmed, 0 excluded

Manufacturer names merged into this page: SMITHS MEDICAL ASD INC. · SMITHS MEDICAL ASD, INC. · SMITHS MEDICAL ASD, INC · SMITHS MEDICAL ASD, INC. (MINNEAPOLIS) · Smiths Medical ASD Inc. · Smiths Medical ASD Inc

Same-named companies — This database also contains companies with near-identical names: FABRICADO POR MEDEX DE MÉXICO SA DE CV, MÉXICO PARA SMITHS MEDICAL ASD, INC., Smith Medical Asd, Inc., SMITHS MEDICAL ASD, INC. (MINNEAPOLIS). Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232943	Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe	2024-05-31
US	K210833	Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula	2021-11-26
US	K211634	Hypodermic Needle-Pro EDGE Safety Device	2021-08-26
BR	10150470076	ESTILETE INTRODUTOR PARA SONDAS ENDOTRAQUEAIS PORTEX	Class II
BR	10150470005	CANULA DE GUEDELL PORTEX	Class II
BR	10150470006	CANULA PARA TRAQUEOSTOMIA PORTEX	Class II
SA	ME0000000688SFDAA00009	CADD®-Solis Li-ion Rechargeable Battery Pack	—
SA	ME0000000688SFDAA00020	Polemount Bracket	—
CA	1862	TRAKE SERIES EMERGENCY AIRWAY ACCESS KITS	Class II
CA	7242	EPISTAXIS CATHETER	Class II
CA	12620	VOICE PROSTHESIS	Class III

Smiths Medical Asd, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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