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Neurovalens

✓ Record-verifiedregistrations found in 4 marketsEU SRN XI-MF-000044791

This company has registrations in European Union, United States, United Kingdom, Hong Kong — 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

1UDI-DI device records

Class IIa 1

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 2Class III 0unclassified 1

plus 5 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

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.

European Union1 raw hits, 0 excluded, 1 confirmed

United States5 registration records, 4 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Manufacturer names merged into this page: NEUROVALENS

Regulatory identity

EU manufacturer SRN: XI-MF-000044791
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

FDA 510(k) clearances by year

12023 · K230826

12024 · K232253

12025 · DEN240076

12026 · DEN250013

FDA listed device types

Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety 1Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms 1Pad, Alcohol, Device Disinfectant 1Cranial Electrotherapy Stimulator For Weight Management 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05070002841234	Modius Sleep	Class IIa
UK	60682	Modius Sleep	Class IIa
US	DEN250013	Modius Spero	2026-05-08
US	DEN240076	Modius Lean	2025-10-17
US	K232253	Modius Stress	2024-03-27

Neurovalens

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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