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Procare

by Uro Technology Sdn. Bhd. Malaysia EUDAMED

Ref 93962460 EMDN U010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09555942811470 Basic UDI-DIDate24 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Medpolly Procare 3 Way Dufour Silicone Elastomer Coated Blue Catheter 24x60 Hard Valve
Sterile Urethral Latex Foley Balloon Catheters
Model / Reference
93962460
Primary DI / UDI-DI
09555942811470, 09555942811487
Basic UDI-DI
B-09555942811470, B-09555942811487
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 (2)

  • EUDAMED a22fe384-3e63-4a0e-86e3-86e900cab4af 61 fields · synced 23 Oct 2026
  • EUDAMED 09555942811487|B-09555942811487 61 fields · synced 19 May 2026