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Mallinckrodt Medical

Ireland · Athlone

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 3 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

7listed device types

Class I 1Class II 6Class III 0

plus 16 registration records and 47 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

19 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

pendingnot queried

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 States16 registration records, 47 510(k), 0 PMA, 14 excluded

Brazil0 confirmed, 3 excluded

Canada3 confirmed, 6 excluded

Manufacturer names merged into this page: Mallinckrodt Medical · MALLINCKRODT MEDICAL

FDA 510(k) clearances by year

41990

61991

11992

51993

131994

71995

41996

51997

12005

12008

FDA listed device types

Tube, Tracheostomy (W/Wo Connector) 1Tube Tracheostomy And Tube Cuff 1Tube, Bronchial (W/Wo Connector) 1Attachment, Breathing, Positive End Expiratory Pressure 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Tube, Tracheal (W/Wo Connector) 1Stylet, Tracheal Tube 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K082520	SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES	2008-10-02
US	K051416	SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA	2005-06-16
US	K972258	HI-CARE CLOSED SUCTION SYSTEM	1997-12-29
CA	1852	ENDOBRONICHIAL TUBE	Class II
CA	7869	SHILEY TRACHEOSOFT DISPOSABLE INNER CANNULA	Class II
CA	13205	SHILEY TRACHEOSOFT TRACHEOSTOMY TUBE	Class II

Mallinckrodt Medical

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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