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RestoreXL

by PathRight Medical United States EUDAMED

Ref 118

EMDN U99

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08600014538RestoreXLL6 Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
118
Primary DI / UDI-DI
00198715725728
Basic UDI-DI
08600014538RestoreXLL6
EMDN Code
U99 Devices for urogenital system - other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000039590
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from PathRight Medical

  • RestoreX

    Class I

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 cb871c31-5ff4-4562-b6af-20b894876ae0 61 fields · synced 23 Oct 2026