Skip to content

Volta AF-Xplorer

by Substrate HD

Ref A002

Volta AF-Xplorer (A002) is a device classified as Class IIa in the EU and Class II in the US made by Substrate Hd, cleared under FDA 510(k) K223516 on 21 Jan 2023, registered in EUDAMED on 22 Aug 2022 (Basic UDI-DI 3770019196A002RL) and listed in FDA GUDID since 9 Mar 2023 (UDI-DI 03770019196038), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223516

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03770019196038 UDI-DI Date9 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223516 Date21 Jan 2023DecidedStatusActive
European UnionCE/MDR EUDAMED Number3770019196A002RL Basic UDI-DI 03770019196038UDI-DIDate22 Aug 2022RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K223516 decided 21 Jan 2023 Active
  • EUDAMED Basic UDI-DI 3770019196A002RL registered 22 Aug 2022 Active
  • FDA GUDID UDI-DI 03770019196038 listed 9 Mar 2023 Listed

Timeline

3 dated events

  1. Registered EUDAMED 3770019196A002RL
  2. Cleared FDA 510(k) K223516
  3. Listed FDA GUDID 03770019196038

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Cardiac mapping system computer
Model / Ref / Catalog
A002
Primary DI / UDI-DI
03770019196038
Basic UDI-DI
3770019196A002RL
Direct marketing DI
03770019196038
FDA product code
DQK
EMDN code
Z12050703 Polygraphy systems for electrophysiological studies
GMDN term
Cardiac mapping system computer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1425
Special device type
Software
EU registration type
Standard device
EU market of registration
France
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.

Manufacturer details

EUDAMED SRN
FR-MF-000000507

Similar devices in this category

Other devices filed under CARDIOGRAPHY INSTRUMENTS.

Other devices from Substrate Hd

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)