Neurovirtual

FDA UDI

Class II (US FDA UDI)

by M F Equipamentos Medicos Ltda Epp

Identity

Trade Name: Neurovirtual FDA UDI
Generic Name: Polysomnograph FDA UDI
Device Name: BWMini PSG: Full-montage standard electroencephalograph device FDA UDI
Model / Reference: BWMini PSG FDA UDI
Description: BWMini PSG: Full-montage standard electroencephalograph device FDA UDI

Identifiers

Catalog Number: PV 2311 FDA UDI
Primary DI / UDI-DI: 00867975000288 FDA UDI
510(k) Number: K131335 FDA UDI
FDA Product Code: GWQ FDA UDI
OLV FDA UDI
GMDN Term: Polysomnograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Polysomnograph Electroencephalograph

Neurovirtual by M F Equipamentos Medicos Ltda Epp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalograph.

Natus — Natus Neurology Incorporated · Class II
Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
Natus — Natus Neurology Incorporated · Class II
Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc. · Class II
Natus — Natus Neurology Incorporated · Class II
128-channel EEG cap (L) — Megin Oy · Class II
Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
Zeto ONE Head Unit - Small — ZETO INC · Class II

Cleared under the same submission

K131335 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: M F Equipamentos Medicos Ltda Epp

Sources (1)

FDA UDI 55a721c4-f2e7-4bc9-81a8-af5e1fd1c1da 36 fields · synced May 30, 2026