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Aris

by Coloplast A/S Denmark EUDAMED

Ref UR3105

EMDN U070101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number570893255591818TF Basic UDI-DIDate3 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Aris transobturator System
Model / Reference
UR3105
Primary DI / UDI-DI
05701780318723
Basic UDI-DI
570893255591818TF
EMDN Code
U070101 Sling systems for the treatment of incontinence
Device Class
Class IIb
Medical Purpose
Aris Transobturator Kit (Aris Kit) consists of a permanent, implantable, midurethral polypropylene sling (Aris) and three disposable introducers, intended to surgically place the sling using a transobturator surgical approach.

Manufacturer details

EUDAMED SRN
DK-PR-000027597

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 05701780318723|570893255591818TF 61 fields · synced 24 Oct 2026