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Bipolar needle electrode

by Spes Medica S.p.A. 12 variants

Ref DSFN380453707

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number18054655008415 UDI-DI Date3 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8054655000001XQ Basic UDI-DI 18054655008415UDI-DIDate15 Jan 2024RegisteredStatusActive

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

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  • Withdrawn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
Bipolar needle electrode EUDAMED
Disposable EMG needle electrodes GUDID
Generic Name
Electromyographic needle electrode, single-use
Device Name
Electromyography (EMG) needle electrodes
Model / Reference
DSFN380453707
Primary DI / UDI-DI
18054655008415
Basic UDI-DI
8054655000001XQ
FDA Product Code
IKT
EMDN Code
N010101 Electromyographic electrodes
GMDN Term
Electromyographic needle electrode, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
890.1385
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
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

  • Sterile
  • 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