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Sudoscan SUDOSCAN2

by Impeto Medical

Ref SUDO2

Sudoscan SUDOSCAN2 (SUDO2) is a device classified as Class IIa in the EU and Class II in the US made by Impeto Medical, registered in EUDAMED on 21 May 2026 (Basic UDI-DI B-03770025753096) and listed in FDA GUDID since 1 Aug 2022 (UDI-DI 03770025753096), active as of 23 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-03770025753096 Basic UDI-DI 03770025753096UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03770025753096 UDI-DI Date1 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03770025753096 registered 21 May 2026 Active
  • FDA GUDID UDI-DI 03770025753096 listed 1 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03770025753096
  2. Registered EUDAMED B-03770025753096

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Sudoscan
Generic name
Skin electrical conductance meter
Model / Ref / Catalog
SUDO2, SUDOSCAN2
Primary DI / UDI-DI
03770025753096
Basic UDI-DI
B-03770025753096
FDA product code
GZO
EMDN code
Z12040114 Systems for the study of autonomic neuropathies
GMDN term
Skin electrical conductance meter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1540
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SUDO2
GUDID
SUDOSCAN2
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: Skin electrical conductance meter

Similar devices in this category

Other devices filed under GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS.

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Properties

  • Measuring function
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)