Neon 12

by Incereb Ltd

Ref TF01

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number539153095TF01CC Basic UDI-DI 05391530950008UDI-DI	Date26 Nov 2023Registered	StatusWithdrawn No longer placed on the EU market
United States	GUDID listing GUDID	Number05391530950008 UDI-DI	Date19 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Withdrawn
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: Neon 12 EUDAMED
neon12 GUDID
Generic Name: Analytical scalp electrode, single-use
Model / Reference: TF01
Description: EEG electrode array sized for use with neonatal infants. The array has qty 12 electrodes. The device is single use only

Primary DI / UDI-DI: 05391530950008
Basic UDI-DI: 539153095TF01CC
510(k) Number: K151576
FDA Product Code: GXY
EMDN Code: N01010299 EEG electrodes - other
GMDN Term: Analytical scalp electrode, single-use

Device Class: Class I EUDAMED
Class II GUDID
Regulation Number: 882.1320
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device Class	EUDAMED Class I	GUDID Class II

Manufacturer details

EUDAMED SRN: IE-MF-000002463

Other devices from Incereb Ltd

Neon10

Class I
Neon12

Class I
Neon EEG

Class II
Neon8

Class I
Neon12

Class I

Properties

Single Use
Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (19)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No