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Compumedics Limited

www.compumedics.com

✓ Record-verifiedregistrations found in 12 marketsEU SRN AU-PR-000057864Unified social credit code 006854897000000000

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 11 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

5China registrations

Class II 5

as of 2026-09-01

EUEuropean UnionEUDAMED

76UDI-DI device records

Class I 10Class IIa 66

USUnited StatesFDA openFDA

12listed device types

Class I 0Class II 12Class III 0

plus 14 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

BRBrazilANVISA

7registered devices

Class II 7

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

2active device licences

Class III 2

40 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

9device registrations

CLASS B 9

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

21active ARTG entries

Class I 5IIa 16

HKHong KongMDACS

5valid listings

Class II 5

ILIsraelAMAR

5registrations

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.

European Union127 raw hits, 51 excluded, 76 confirmed

United States14 registration records, 9 510(k), 0 PMA, 6 excluded

China5 certificates (Class III 0 / II 5 / I 0), as of 2026-09-01

United Kingdom1 confirmed, 1 excluded

Brazil7 confirmed, 1 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: COMPUMEDICS LIMITED

Regulatory identity

EU manufacturer SRN: AU-PR-000057864
EU authorised representative: Compumedics EUROPE GmbH
UK responsible person: ADVANCED MEDICAL EQUIPMENT, LTD
Unified social credit code: 006854897000000000
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

12000

12003

12008

12010

12020

22023

22025

FDA listed device types

showing 8 of 12

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

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注进20152073889	脑电图机EEG Amplifier and Data Acquisition system	Class II · 2026-03-03
CN	国械注进20192072456	脑电图仪Full-montage Standard Electroencephalograph	Class II · 2026-01-29
CN	国械注进20212210121	脑电数据管理软件Profusion EEG software	Class II · 2025-11-13
CN	国械注进20152212437	多导睡眠分析软件Polysomnography(PSG) Analyzing Software	Class II · 2024-07-29
EU	09342451006646	Falcon HST Disposable Study Kit	Class IIa
EU	09342451005885	Somfit Pro Overnight Study Consumables Pack	Class IIa
EU	09342451001283	Grael LT	Class IIa
EU	09342451001306	Grael PSG	Class IIa
UK	33843	Somfit System	Class IIa
US	K252383	Somfit D	2025-08-28
US	K242447	Falcon HST	2025-02-20
US	K231546	Somfit	2023-11-30
BR	81346509067	GRAEL LT - CM Compumedics	Class II
BR	81346509068	GRAEL PSG - Sistema Polissonografia - CM Compumedics	Class II
BR	81346509069	GRAEL EEG - Sistema Eletroencefalográfico - CM Compumedics	Class II
CA	66320	E-SERIES EEG SYSTEM	Class III
CA	67244	E-SERIES EEG/PSG SYSTEM	Class III