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Kegel8®

by Verity Medical Ltd. Ireland EUDAMED

Ref OPH400AModel Kegel8® Tight and Tone

EMDN Z12062899

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506007397OPH400A89 Basic UDI-DIDate20 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • 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
Kegel8® Tight and Tone, OPH400A
Primary DI / UDI-DI
05060073978779
Basic UDI-DI
506007397OPH400A89
Direct Marketing DI
05060073978779
EMDN Code
Z12062899 Neuromuscular stimulation equipment - other
Device Class
Class IIa

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 2a6a32fe-560c-4d45-ae03-a38b14166f00 61 fields · synced 22 Oct 2026