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Procare

by Uro Technology Sdn. Bhd. Malaysia EUDAMED

Ref 3311830

EMDN U010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09555942808418 Basic UDI-DIDate24 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sterile Urethral Latex Foley Balloon Catheters
Model / Reference
3311830
Primary DI / UDI-DI
09555942808418
Basic UDI-DI
B-09555942808418
EMDN Code
U010202 Urethral prostatic and bladder catheters, couvelaire, with balloon
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
MY-MF-000001248
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Uro Technology Sdn. Bhd.

See all devices from Uro Technology Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (9)
  • Implantable: No
  • Reusable: 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 f7cd89e7-1df8-4a64-bc86-509afd884f0e 61 fields · synced 24 Oct 2026