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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
This device is the replacement of Enobio Dx's component Earclip. Earclip is the electrical reference electrode. It is a dual electrode used to connect both CMS and DRL simultaneously to the same earlobe. 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
Earclip - Component Replacement: Enobio Dx FDA UDI
Description
This device is the replacement of Enobio Dx's component Earclip. Earclip is the electrical reference electrode. It is a dual electrode used to connect both CMS and DRL simultaneously to the same earlobe. 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
18437017440618 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

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.

Cleared under the same submission

K162681 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neuroelectrics Barcelona Sl

Sources (1)

  • FDA UDI 7e31f204-af0b-418c-8e0a-2644c0c4a333 36 fields · synced May 30, 2026