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Adhesive electrodes

by Spes Medica S.p.A. 28 variants

Ref DENIL06026, DENIL10026, DENIGS25026, DENIS01500, TABSMP00K100, TABSM000K105, DENIS10026, DENIB15026, DENID00807, DAEDS1604, DENIB25026, DENIS01526, DENIS06026, DENIL15026, DENIL01500, TABSM000K100, DENIG10026, CDES002822, CDES000020

Active European Union

CE MDR

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/MDR Number8054655000014XZ Basic UDI-DI Date24 Apr 2023RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Adhesive electrodes for Neurodiagnostic, Cardiology and Electrostimulation
Model / Reference
DENIL06026, DENIL10026, DENIGS25026, DENIS01500, TABSMP00K100, TABSM000K105, DENIS10026, DENIB15026, DENID00807, DAEDS1604, DENIB25026, DENIS01526, DENIS06026, DENIL15026, DENIL01500, TABSM000K100, DENIG10026, CDES002822, CDES000020
Primary DI / UDI-DI
18054655007425, 18054655016076, 18054655034766, 18054655007555, 18054655018452, 18054655019619, 18054655007685, 18054655022572, 18054655007258, 18054655006480, 18054655028147, 18054655007500, 18054655007654, 18054655007456, 18054655007364, 18054655018445, 18054655018421, 18054655019909, 18054655017226
Basic UDI-DI
8054655000014XZ
EMDN Code
N010199 Neurophysiology devices - other
Device Class
Class I
EU market of registration
Italy

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

Other properties (13)

  • 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