Skip to content

Sanibel EARturtle Universal Box of 36 kits w/tab electrodes

by DGS Diagnostics A/S

Ref 8537209Model EARturtle with electrodes

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

CE MDR

Valid until

Not listed

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

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
United StatesGUDID listing GUDID Number05711117230802 UDI-DI Date14 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5711117_P-0000556_02_YN Basic UDI-DI 05711117230802UDI-DIDate11 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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 EARturtle Universal Box of 36 kits w/tab electrodes EUDAMED
Sanibel Supply A/S GUDID
Generic Name
Vestibulo-auditory analysis system support kit¿
Model / Ref / Catalog
EARturtle with electrodes, 8537209, Sanibel EARturtle Universal Box of 36 kits w/tab electrodes
Primary DI / UDI-DI
05711117230802
Basic UDI-DI
5711117_P-0000556_02_YN
FDA Product Code
ETT, GXY
EMDN Code
Z12140385 Evoked potential audiometry instruments - consumables
GMDN Term
Vestibulo-auditory analysis system support kit¿
Device Class
Class I
Regulation Number
874.1100, 882.1320
Medical Purpose
Medical device accessories intended for ABR measurements
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
EARturtle with electrodes
8537209
GUDID
Sanibel EARturtle Universal Box of 36 kits w/tab electrodes

Manufacturer details

EUDAMED SRN
DK-PR-000031217

Other devices from DGS Diagnostics A/S

See all devices from DGS Diagnostics A/S →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No