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NEUROVIRTUAL USA, INC.

USA · Fort Lauderdale

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Taiwan — 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

8listed device types

Class I 1Class II 7Class III 0

plus 10 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

10 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

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 States10 registration records, 8 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: NEUROVIRTUAL USA, INC. · NEUROVIRTUAL USA INC. · NEUROVIRTUAL USA INC

FDA 510(k) clearances by year

12006 · K062533

12011 · K112107

12015 · K131335

12017 · K163547

12019 · K171304

32020 · K201495

FDA listed device types

Electrode, Cutaneous 1Monitor, Breathing Frequency 1Ventilatory Effort Recorder 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Oximeter 1Full-Montage Standard Electroencephalograph 1Standard Polysomnograph With Electroencephalograph 1Cannula, Nasal, Oxygen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201495	Maxxi Flow Sensor	2020-12-14
US	K191492	Maxxi Position Sensor	2020-04-24
US	K191095	Maxxi Snore Sensor	2020-01-16
BR	80193719005	BWIII EEG/PSG	Class II
BR	80193719006	BWMini EEG/PSG	Class II
BR	80193710015	Neurovirtual Cloud - Software para leitura de exames de polissonografi	Class II

NEUROVIRTUAL 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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