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Procare

by Uro Technology Sdn. Bhd. Malaysia EUDAMED

Ref 9385S2410

EMDN U010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09555942811289 Basic UDI-DIDate24 Jan 2025RegisteredStatusActive

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
9385S2410
Primary DI / UDI-DI
09555942811289
Basic UDI-DI
B-09555942811289
EMDN Code
U010199 Urethral prostatic and bladder catheters, not self-retained - other
Device Class
Class IIb
Market of Registration
Romania

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 3de3a9aa-2cac-425b-b3f4-5d023c2b7520 61 fields · synced 24 Oct 2026