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Sanibel TM electrode

by Interacoustics A/S

Ref 8049550Model TM Electrode

Sanibel TM electrode is an analytical non-scalp cutaneous electrode (EU MDR Class I; FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Interacoustics A/S, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI 5711117_P-0000496_SS) and listed in FDA GUDID since 9 Feb 2018 (UDI-DI 05711117180572), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5711117_P-0000496_SS Basic UDI-DI 05711117180572UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05711117180572 UDI-DI Date9 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5711117_P-0000496_SS registered 10 Jul 2026 Active
  • FDA GUDID UDI-DI 05711117180572 listed 9 Feb 2018 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 05711117180572
  2. Registered EUDAMED 5711117_P-0000496_SS

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  • Withdrawn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
Sanibel TM Electrode EUDAMED
Sanibel GUDID
Generic name
Analytical non-scalp cutaneous electrode
Model / reference
TM electrode, 8049550
Primary DI / UDI-DI
05711117180572
Basic UDI-DI
5711117_P-0000496_SS
FDA product code
GXY
EMDN code
Z12140385 Evoked potential audiometry instruments - consumables
GMDN term
Analytical non-scalp cutaneous electrode
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Analytical non-scalp cutaneous electrode

Similar devices in this category

Other devices filed under EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS.

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Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)