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4X1 HD-tDCS: Multi-Channel Stimulation Interface

by Soterix Medical Inc.

Ref 4x1-C3A

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00860008346858 Basic UDI-DI 00860008346858UDI-DIDate18 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
4X1 HD-tDCS: Multi-Channel Stimulation Interface
Model / Reference
4x1-C3A
Primary DI / UDI-DI
00860008346858
Basic UDI-DI
B-00860008346858
EMDN Code
Z12101180 Peripheral or central neuro stimulation and assessment instruments - hardware accessories
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
US-MF-000012130
Authorised representative
mdi Europa GmbH DE-AR-000006218

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Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No