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Substrate Hd

Active in EUDAMED

Francefrom SRN EUDAMED SRN FR-MF-000000507

Substrate Hd is a medical device manufacturer based in France, with 7 devices listed in EUDAMED and FDA GUDID (EU Class I and IIa; FDA Class II) as of 13 Nov 2026.

Devices
7
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 6
  • FDA GUDID 3

A device listed in two registries counts in both.

Device classes
  • EU Class I 3
  • EU Class IIa 3
  • FDA Class II 1
Top EMDN categories
Identifiers
  • EUDAMED SRN FR-MF-000000507
  • DUNS 268244729

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Substrate Hd makes

Substrate HD develops and supplies cardiac mapping systems, including both hardware and software solutions for electroanatomical mapping in cardiac procedures. Their portfolio includes systems for real-time visualization of cardiac electrical activity, such as the VX1 platform and its associated applications, as well as specialized tools like the Volta AF-Xplorer series for atrial fibrillation mapping. Additional offerings include the DSUB and OCTOPUS systems, designed for precise intracardiac navigation and data acquisition during electrophysiological studies.

The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIa, with corresponding listings in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. Their products are also subject to regulatory compliance under French and European Union medical device directives. Substrate HD operates as a manufacturer based in France.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue7

Newest first, rows 1-7 of 7

  • VX1 A001

    Active Regimes: 510(k) Registry: GUDID Class:II

  • VX1 Hardware Ref H001

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:I

  • Dsub Ref H005

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Volta AF-Xplorer Ref A002

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • VX1 Application Ref S001

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Volta AF-Xplorer II Ref A003

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Octopus Ref H007

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000000507
DUNS number
268244729
EU VAT number
FR14820967875
EUDAMED status
Active
EUDAMED registered name
Substrate HD
EUDAMED abbreviated name
Volta Medical
Registered address
65, Avenue Jules Cantini, 13006, Marseille, France
PRRC contact
Paola Milpied(public in EUDAMED)

Frequently asked questions

How many devices does SUBSTRATE HD have in the registry?

The registry currently lists 7 devices for SUBSTRATE HD. Devices recorded under merged duplicate company entries are counted once.

Which registries list SUBSTRATE HD's devices?

Among its 7 most recently registered devices, SUBSTRATE HD has devices listed in EUDAMED (6 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do SUBSTRATE HD's devices fall under?

Among its 7 most recently registered devices, the classes recorded for SUBSTRATE HD's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from SUBSTRATE HD in the registry?

The most recently registered devices listed for SUBSTRATE HD include VX1 A001, VX1 Hardware, DSUB and Volta AF-Xplorer.

Generated automatically from registry data and not verified by a human reviewer.