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Accessory Box AB02 100207

by PATH medical GmbH

Part of a family of 27 devices: see the family page

Ref 100207Model 100120

Accessory Box AB02 100207 is a device classified as Class IIa in the EU and Class II in the US made by PATH medical GmbH, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0426022Probes-2aTM) and listed in FDA GUDID since 2 Jun 2017 (UDI-DI 04260223140723), active as of 23 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0426022Probes-2aTM Basic UDI-DI 04260223140723UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260223140723 UDI-DI Date2 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0426022Probes-2aTM registered 28 May 2026 Active
  • FDA GUDID UDI-DI 04260223140723 listed 2 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260223140723
  2. Registered EUDAMED 0426022Probes-2aTM

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  • Withdrawn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
Accessory Box Sentiero ECO EUDAMED
Accessory Box AB02 GUDID
Generic name
Evoked-potential audiometer
Device name
Ep-Te
Model / reference
100207, 100120
Primary DI / UDI-DI
04260223140723
Basic UDI-DI
0426022Probes-2aTM
FDA product code
GWJ
EMDN code
Z12140380, Z12149001
GMDN term
Evoked-potential audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1900
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 PATH medical GmbH

See all devices from PATH medical GmbH →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Manufacturing date
Other properties (21, all answered No)