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COMPUMEDICS USA, INC.

USA · Charlotte

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Australia — 4 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

12listed device types

Class I 0Class II 12Class III 0

plus 14 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

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

9 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 2IIa 4

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 States14 registration records, 3 510(k), 0 PMA, 6 excluded

Brazil0 confirmed, 2 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: COMPUMEDICS USA, INC.

FDA 510(k) clearances by year

12003 · K033052

12004 · K040194

12008 · K081151

FDA listed device types

showing 8 of 12

Stimulator, Electrical, Evoked Response 1Media, Electroconductive 1Electrode, Cutaneous 1Stimulator, Photic, Evoked Response 1Ventilatory Effort Recorder 1Automatic Event Detection Software For Polysomnograph With Electroencephalograph 1Stimulator, Auditory, Evoked Response 1Magnetoencephalograph 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K081151	COMPUMEDICS NEUVO	2008-09-08
US	K040194	COMPUMEDICS SUMMIT IP	2004-04-23
US	K033052	CONDUCTIVE EEG ELECTROLYTE	2003-12-17
CA	30482	COMPERIO	Class II
CA	60986	NEUROSCAN SCAN LT	Class II
CA	61193	SOURCE ELECTROENCEPHALOGRAPH (EEG) SOFTWARE	Class II

COMPUMEDICS USA, 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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