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RENOVA iStim™ OAB2000

by BlueWind Medical Ltd Israel EUDAMED

Ref MA-1007-0600 EMDN U0799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-MA-1007-060033 Basic UDI-DIDate13 Mar 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/AIMDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Peripheral Nerve Stimulation System
Model / Reference
MA-1007-0600
Primary DI / UDI-DI
D-MA-1007-060033
Basic UDI-DI
B-MA-1007-060033
EMDN Code
U0799 Devices for the treatment of incontinence - other
Device Class
Class AIMDD

Manufacturer details

EUDAMED SRN
IL-MF-000009870
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Bluewind Medical Ltd.

  • Revi System

    Class II

  • Revi System

    Class II

  • Revi System

    Class II

  • Revi System

    Class II

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 4d4aa30e-54a9-45f1-b507-c10c5731a9d9 61 fields · synced 25 Oct 2026