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TENS Electrode

by Spes Medica S.p.A. 4 variants

Ref 8703712, BAND08040, SBM1AE003, 8703714, TEON1F5045

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number18054655030515 UDI-DI Date13 May 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8054655000017Y7 Basic UDI-DI Date21 Apr 2023RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TENS Electrode EUDAMED
Connection cable GUDID
Disposable Adhesive Surface Electrodes GUDID
Generic Name
Analytical non-scalp cutaneous lead
Electromyographic needle electrode, single-use
Device Name
Electrodes for Electrotherapy and accessories
Model / Reference
8703712, BAND08040, SBM1AE003, 8703714, TEON1F5045
Primary DI / UDI-DI
18054655030515, 18054655001294, 18054655021711, 18054655030539, 18054655014850
Basic UDI-DI
8054655000017Y7
510(k) Number
FDA Product Code
IKD, GXY
EMDN Code
N010201 Tens system electrodes
GMDN Term
Analytical non-scalp cutaneous lead
Electromyographic needle electrode, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.1175, 882.1320
EU market of registration
Italy
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000008858

Other devices from Spes Medica S.p.A.

See all devices from Spes Medica S.p.A. →

Properties

  • Single Use NoGUDIDYesGUDID
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number
  • Expiration Date NoGUDIDYesGUDID
  • Manufacturing Date YesGUDIDNoGUDID

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No