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Smith Medical Asd, Inc.

USA · St. Paul

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel — 5 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

62registered devices

Class I 10Class II 52

63 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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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.

United States0 registration records, 53 510(k), 18 PMA

Brazil62 confirmed, 2 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. · 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., Smiths 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

Smith 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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