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EB Neuro S.p.A.

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel, Russia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

11listed device types

Class I 0Class II 11Class III 0

plus 8 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

2active device licences

Class II 2

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 3

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 Union58,582 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States8 registration records, 13 510(k), 0 PMA

United Kingdom0 confirmed, 93 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: EB NEURO S.P.A. · EB NEURO, S.P.A. · EBNEURO S.P.A.

Regulatory identity

Exhibition record: CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

12001

22004

22006

12008

12010

12012

12014

22015

22024

FDA listed device types

showing 8 of 11

Stimulator, Electrical, Evoked Response 1Amplifier, Physiological Signal 1Stimulator, Photic, Evoked Response 1Electromyograph, Diagnostic 1Non-Normalizing Quantitative Electroencephalograph Software 1Ventilatory Effort Recorder 1Device, Nerve Conduction Velocity Measurement 1Stimulator, Auditory, Evoked Response 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242832	NExT Station; NExT Station Advanced	2024-12-12
US	K242305	BE Plus PRO, Neurotravel LIGHT	2024-09-04
US	K150220	STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast	2015-08-19
CA	61093	BASIS BE	Class II
CA	68278	BASIS BE	Class II

EB Neuro S.p.A.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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