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Wandy Silicon Conductive Rubber Pad

by Wandy Rubber Industrial Co., Ltd

Ref Q-01Model Q01 (38x45mm,1.5x1.77in)

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471988924Q-TYPERM Basic UDI-DI 04719889241324UDI-DIDate27 Jan 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK002227 Date2 Feb 2001IssuedStatusActive

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 24 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  • Withdrawn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
Silicon Conductive Rubber Pad
Model / Reference
Q01 (38x45mm, 1.5x1.77in), Q-01
Primary DI / UDI-DI
04719889241324
Basic UDI-DI
471988924Q-TYPERM
EMDN Code
N010201 Tens system electrodes
Device Class
Class I
EU market of registration
Hungary

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

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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