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Pacey Cuff – Ultra Urethral Control Device

by Pacey Medtech Limited EUDAMED

Active European Union

Ref SUCD-U

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890357SUCDULW Basic UDI-DIDate2 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Pacey Cuff
Model / Reference
SUCD-U
Primary DI / UDI-DI
08903570000574
Basic UDI-DI
890357SUCDULW
EMDN Code
T0499 Incontinence devices - other
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CA-MF-000056201
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Pacey Medtech Ltd.

Properties

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