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Covalon Technologies, Ltd.

Canada · Mississauga

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Hong Kong, Israel — 6 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 3Class II 0Class III 0unclassified 1

plus 6 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 2

10 including historic records

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

5active device licences

Class II 2Class IV 3

17 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

3valid listings

Class IV 3

ILIsraelAMAR

10registrations

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, 3 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: COVALON TECHNOLOGIES INC. · COVALON TECHNOLOGIES, INC. · Covalon Technologies Ltd. · Covalon Technologies INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K123756	COVAGEN	2013-08-16
US	K060804	COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING	2006-04-18
US	K052696	COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING	2006-02-03
BR	10178010306	CovaClear IV	Class I
BR	10178010307	VALGuard - Protetor de acesso vascular	Class I
BR	10306840178	MediClear Scar	Class II
SA	ME0000006405SFDAA00017	AquaGuard	—
SA	ME0000006317SFDAA00001	AquaGuard	—
CA	69776	COLACTIVE COLLAGEN DRESSING	Class IV
CA	69777	COLACTIVEAG COLLAGEN WITH SILVER, ANTIMICROBIAL WOUND DRESSING	Class IV
CA	69779	COVACLEAR AG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING	Class IV

Covalon Technologies, Ltd.

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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