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Embla Systems, Inc.

Canada · Kanata

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Israel — 5 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

9510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 9 510(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

9active device licences

Class II 9

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States0 registration records, 9 510(k), 0 PMA

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: EMBLA SYSTEMS · EMBLA SYSTEMS LLC

Business registration

Legal name: Embla Systems Ltd.
Corporation number: 4334850
Registration status: Active
Legal form: Canada Business Corporations Act
Incorporated: 2005-11-23
Registered address: 100 King Street West, Toronto, ON, M5X 1B8

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180001	Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant	2019-09-27
US	K173793	XactTrace Single Use Respiratory Effort Belt System	2019-03-01
US	K172703	Disposable Snap Electrode	2017-11-13
CA	60617	SANDMAN DIGITAL32+ (SD32+) AMPLIFIER	Class II
CA	68876	EEG ELECTRODES - CUTANEOUS - GOLD	Class II
CA	76760	TITANIUM RECORDING SYSTEM	Class II

Embla Systems, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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