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Neon8

by Incereb Ltd

Ref TF04K, TF04-IT

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number539153095TF04KAQ Basic UDI-DI Date12 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05391530950107 UDI-DI Date24 Mar 2022ListedStatusListed 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 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Neon8 EUDAMED
Neon8 KIT GUDID
Generic Name
Analytical scalp electrode, single-use
Model / Reference
TF04K, TF04-IT
Primary DI / UDI-DI
05391530950107, 05391530950169
Basic UDI-DI
539153095TF04KAQ
Direct Marketing DI
05391530950107
510(k) Number
FDA Product Code
GXY
EMDN Code
N01010299, N01010202
GMDN Term
Analytical scalp electrode, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1320
EU market of registration
Ireland
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
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

  • 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