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Adhesive electrodes

by Spes Medica S.p.A. 10 variants

Ref CDE02460F4

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
European UnionCE/MDR EUDAMED Number8054655000014XZ Basic UDI-DI 18054655005049UDI-DIDate24 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number18054655005049 UDI-DI Date21 Jun 2016ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Adhesive electrodes EUDAMED
Disposable Adhesive Surface Electrodes GUDID
Generic Name
Electromyographic needle electrode, single-use
Device Name
Adhesive electrodes for Neurodiagnostic, Cardiology and Electrostimulation
Model / Reference
CDE02460F4
Primary DI / UDI-DI
18054655005049
Basic UDI-DI
8054655000014XZ
510(k) Number
FDA Product Code
GXY
EMDN Code
N010199 Neurophysiology devices - other
GMDN Term
Electromyographic needle electrode, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1320
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

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

  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No