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Edge Systems Corporation

USA · Signal Hill

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Israel, Russia — 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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, 3 510(k), 0 PMA, 20 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: EDGE SYSTEMS CORPORATION · Edge Systems LLC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K072399	DEL SOL RED LIGHT THERAPY SYSTEM	2008-05-23
US	K061470	DEL SOL BLUE LIGHT THERAPY SYSTEM	2006-07-20
US	K990748	EDGE SYSTEMS STERILE TUBING	1999-05-04
SA	ME0000006226SFDAA00001	HydraFacial MD Tower System 240V	—
SA	ME0000006226SFDAA00002	HydraFacial MD Elite	—
CA	60789	MICRODERMABRASION DEVICE	Class II
CA	60790	OXYMAX OXYGEN CONCENTRATOR	Class II

Edge Systems Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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