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EPTE BIPOLAR System

by Ionclinics & Deionic, S.L.

Ref EPTEV02DEV01Model EPTEV02

EPTE BIPOLAR System (EPTEV02DEV01) is a medical device (EU MDR Class IIa; EMDN category neuromuscular stimulation equipment) made by Ionclinics & Deionic, S.L., registered in EUDAMED on 27 Jul 2023 (Basic UDI-DI 8437023158EPTEV02LQ), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437023158EPTEV02LQ Basic UDI-DI 08437023158012UDI-DIDate27 Jul 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Epte Bipolar
Model / reference
EPTEV02, EPTEV02DEV01
Primary DI / UDI-DI
08437023158012
Basic UDI-DI
8437023158EPTEV02LQ
EMDN code
Z12062899 Neuromuscular stimulation equipment - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000020207

From the manufacturer

Manufacturer's product page: EPTE Bipolar tDCS

Similar devices in this category

Other devices filed under NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER.

Other devices from Ionclinics & Deionic, S.L.

Properties

Other properties (14, all answered No)