Skip to content

Wandy Self-adhesive Electrodes

by Wandy Rubber Industrial Co., Ltd 2 variants

Ref P4-50x50mm-TModel wire type, example model name : P4-50x50mm-058-U (No Tab)

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132998↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471988924P4-50x50mm-U5W Basic UDI-DI 04719889240075UDI-DIDate25 Jul 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK132998 Date20 Dec 2013IssuedStatusActive

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 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Self-adhesive Electrodes
Model / Reference
wire type, example model name : P4-50x50mm-058-U (No Tab), P4-50x50mm-T
Primary DI / UDI-DI
04719889240075
Basic UDI-DI
471988924P4-50x50mm-U5W
Direct Marketing DI
04719889240075
EMDN Code
N010201 Tens system electrodes
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000013312
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Wandy Rubber Industrial Co., Ltd

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