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Sanibel Supply Infant EarCup w/Tab electrodes

by Interacoustics A/S

Ref 8049600Model Infant EarCup w/ electrodes

Sanibel Supply Infant EarCup w/Tab electrodes (8049600) is a device classified as Class I in the EU and Class II in the US made by Interacoustics A/S, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 5711117_P-0000556_01_YK) and listed in FDA GUDID since 30 Dec 2022 (UDI-DI 05711117126006), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5711117_P-0000556_01_YK Basic UDI-DI 05711117126006UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05711117126006 UDI-DI Date30 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5711117_P-0000556_01_YK registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 05711117126006 listed 30 Dec 2022 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 05711117126006
  2. Registered EUDAMED 5711117_P-0000556_01_YK

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  • Withdrawn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 Infant EarCup w/Tab Electrodes EUDAMED
Sanibel Supply GUDID
Generic name
Evoked-potential audiometer
Model / Ref / Catalog
Infant EarCup w/ electrodes, 8049600, Infant EarCup w/Tab electrodes
Primary DI / UDI-DI
05711117126006
Basic UDI-DI
5711117_P-0000556_01_YK
FDA product code
GXY, ETT, GWJ
EMDN code
Z12140385 Evoked potential audiometry instruments - consumables
GMDN term
Evoked-potential audiometer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320, 874.1100, 882.1900
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Medical device accessories intended for ABR measurements
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Infant EarCup w/ electrodes
8049600
GUDID
Infant EarCup w/Tab electrodes
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: Evoked-potential audiometer

Similar devices in this category

Other devices filed under EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS.

Other devices from Interacoustics A/S

See all devices from Interacoustics A/S →

Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)