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ADVANCED BRAIN MONITORING, INC.

USA · Carlsbad

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, 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

7listed device types

Class I 0Class II 7Class III 0

plus 10 registration records and 15 510(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

5 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 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 States10 registration records, 15 510(k), 0 PMA, 21 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia0 confirmed, 2 excluded

Manufacturer names merged into this page: ADVANCED BRAIN MONITORING, INC.

FDA 510(k) clearances by year

12004

12007

32011

32012

32013

12014

12015

12016

12018

FDA listed device types

Device, Anti-Snoring 1Ventilatory Effort Recorder 1Automatic Event Detection Software For Polysomnograph With Electroencephalograph 1Reduced- Montage Standard Electroencephalograph 1Full-Montage Standard Electroencephalograph 1Pillow, Cervical (For Mild Sleep Apnea) 1Standard Polysomnograph With Electroencephalograph 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172799	Positional Sleep Assessment System (PoSAS) software	2018-03-09
US	K153412	Sleep Profiler	2016-03-14
US	K152040	X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)	2015-10-30

ADVANCED BRAIN MONITORING, INC.

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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