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LAC-MAC LIMITED

Canada · London Ontario

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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

5listed device types

Class I 1Class II 4Class III 0

plus 6 registration records and 6 510(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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

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 States6 registration records, 6 510(k), 0 PMA

Brazil0 confirmed, 2 excluded

Manufacturer names merged into this page: LAC-MAC LIMITED

FDA 510(k) clearances by year

22003 · K031362

12004 · K032631

12006 · K061491

12009 · K092344

12011 · K102864

FDA listed device types

Wrap, Sterilization 1Drape, Surgical, Antimicrobial 1Gown, Surgical 1Drape, Surgical, Exempt 1Non-Surgical Gown 1

Market	Identifier	Name	Class / date
US	K102864	84E SERIES SINGLE PLY WRAPPER	2011-01-14
US	K092344	LAC-MAC INNERBLOC LR SURGICAL GOWNS	2009-12-17
US	K061491	LAC-MAC INNERBLOC O.R. GOWN	2006-08-09

LAC-MAC 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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