Enobio Dx

FDA UDI

Class II (US FDA UDI)

by Neuroelectrics Barcelona Sl

Identity

Trade Name: Enobio Dx FDA UDI
Generic Name: Electroencephalographic monitoring system FDA UDI
Device Name: Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designated for use in a clinical environment or hospital. Enobio Dx use must be controlled by specialized medical personnel able to guarantee the correct recording. FDA UDI
Model / Reference: Enobio Dx 32 FDA UDI
Description: Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designated for use in a clinical environment or hospital. Enobio Dx use must be controlled by specialized medical personnel able to guarantee the correct recording. FDA UDI

Identifiers

Primary DI / UDI-DI: 18436612820283 FDA UDI
510(k) Number: K162681 FDA UDI
FDA Product Code: GWQ FDA UDI
GWL FDA UDI
GMDN Term: Electroencephalographic monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
882.1835 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electroencephalographic monitoring system

Enobio Dx by Neuroelectrics Barcelona Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalographic monitoring system.

Pegasus Software License 256ch — NEURALYNX, INC. · Class II
Pegasus Software License 224ch — NEURALYNX, INC. · Class II
Pegasus Software License 416ch — NEURALYNX, INC. · Class II
ATLAS NK HEADBOX — NEURALYNX, INC. · Class II
NetCom Client — NEURALYNX, INC. · Class II
REMI — Epitel, Inc. · Class II
REMI — Epitel, Inc. · Class II
Pegasus Software License 352ch — NEURALYNX, INC. · Class II

Cleared under the same submission

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: Neuroelectrics Barcelona Sl

Sources (1)

FDA UDI b18921cd-d0da-4290-bd3c-1c2a16b32a65 36 fields · synced May 30, 2026