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THE LARYNGEAL MASK COMPANY LIMITED

USA · Victoria

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 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

4listed device types

Class I 1Class II 3Class III 0

plus 5 registration records and 4 510(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

1active device licences

Class II 1

13 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

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 States5 registration records, 4 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: The Laryngeal Mask Company (M) SDN. BHD. · THE LARYNGEAL MASK COMPANY LIMITED

FDA 510(k) clearances by year

12000 · K991580

12005 · K051993

12007 · K062475

12014 · K130304

FDA listed device types

Implantable Transprostatic Tissue Retractor System 1Tube, Tracheal (W/Wo Connector) 1Cuff, Tracheal Tube, Inflatable 1Airway, Oropharyngeal, Anesthesiology 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130304	LMA FAMILY OF AIRWAYS	2014-05-30
US	K062475	LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM	2007-05-09
US	K051993	LMA FASTRACH ETT SINGLE USE	2005-12-13
CA	80757	LMA PLATINUM CLASSIC LARYNGEAL MASK	Class II

THE LARYNGEAL MASK COMPANY LIMITED

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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