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Brainscope Company, Inc.

USA · Rockville

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

3listed device types

Class I 0Class II 3Class III 0

plus 3 registration records and 8 510(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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States3 registration records, 8 510(k), 0 PMA

Manufacturer names merged into this page: BRAINSCOPE · BRAINSCOPE COMPANY INC.

FDA 510(k) clearances by year

12009 · K082886

12014 · DEN140025

12015 · K143643

12016 · K161068

22018 · K181785

22019 · K190815

FDA listed device types

Computerized Cognitive Assessment Aid 1Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid 1Normalizing Quantitative Electroencephalograph Software 1

Market	Identifier	Name	Class / date
US	K190815	BrainScope TBI	2019-09-11
US	K183241	BrainScope TBI (Model: Ahead 400)	2019-02-19
US	K181785	Modified BrainScope One	2018-12-19

Brainscope Company, 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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