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1X1 tES: 1X1 Low Intensity tES Stimulator

by Soterix Medical Inc.

Ref 2001tEModel 2001

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00860008346841 Basic UDI-DI 00860008346841UDI-DIDate17 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
1X1 tES: 1X1 Low Intensity tES Stimulator
Model / Reference
2001, 2001tE
Primary DI / UDI-DI
00860008346841
Basic UDI-DI
B-00860008346841
EMDN Code
Z12101106 Neurological stimulators
Device Class
Class IIa
EU market of registration
France

Manufacturer details

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

Other devices from Soterix Medical, Inc.

See all devices from Soterix Medical, Inc. →

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