Skip to content

Procare

by Uro Technology Sdn. Bhd. Malaysia EUDAMED

Ref 3412660

EMDN U010204

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09555942808500 Basic UDI-DIDate25 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 23 Oct 2026

Device Name
Sterile Urethral Latex Foley Balloon Catheters
Model / Reference
3412660
Primary DI / UDI-DI
09555942808500
Basic UDI-DI
B-09555942808500
EMDN Code
U010204 Urethral prostatic and bladder catheters, dufour, 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
  • Implantable
  • Contains Latex
Other properties (8)
  • 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 c2584bdb-8c19-44fb-a5dc-530fd74b0cab 61 fields · synced 23 Oct 2026