Skip to content

Kegel8® V for Men

by Verity Medical Ltd. Ireland EUDAMED

Ref OPH225 EMDN Z12062899

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506007397OPH22555 Basic UDI-DIDate3 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Neuromuscular electrical stimulator (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS) unit, battery powered
Model / Reference
OPH225
Primary DI / UDI-DI
05060073970537
Basic UDI-DI
506007397OPH22555
Direct Marketing DI
05060073970537
EMDN Code
Z12062899 Neuromuscular stimulation equipment - other
Device Class
Class IIa
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000007426

Other devices from Verity Medical Ltd.

See all devices from Verity Medical Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 96f284ca-32c9-4087-8295-c12fa779b458 61 fields · synced 22 Oct 2026