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Manawa Access Sheath

by Envaste Ltd EUDAMED

Active European Union

Ref UAS-0114020SModel Manawa Access Sheath

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number60913190UASWF Basic UDI-DIDate2 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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.

Specification

EUDAMED

Model / Reference
Manawa Access Sheath, UAS-0114020S
Primary DI / UDI-DI
60913190403792
Basic UDI-DI
60913190UASWF
EMDN Code
U03010202 Ureteral dilators
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
MU-MF-000030801
Authorised representative
ENVASTE LTD IE-AR-000028866

Related devices

Category: Ureteral introduction sheath

Other devices from Envaste Ltd

See all devices from Envaste Ltd →

Properties

  • Sterile

Other properties (12)

  • 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