Neurovirtual

FDA UDI

Class II (US FDA UDI)

by M F Equipamentos Medicos Ltda Epp

Identity

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

Identifiers

Catalog Number: PV 2312 FDA UDI
Primary DI / UDI-DI: 00867975000271 FDA UDI
510(k) Number: K131335 FDA UDI
FDA Product Code: GWQ FDA UDI
OLV FDA UDI
GMDN Term: Electroencephalograph 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

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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

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Manufacturer

Manufacturer: M F Equipamentos Medicos Ltda Epp

Sources (1)

FDA UDI cf52d684-5397-462d-a58f-c845317d4493 36 fields · synced May 30, 2026