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CareFlow

by Uro Technology Sdn. Bhd. EUDAMED

Active European Union

Ref 01/01/10/22/30, 01/01/15/22/60, 01/01/10/20/30, 01/01/10/14/30, 01/01/15/24/60, 01/01/10/18/30

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09555942810053 Basic UDI-DIDate4 Sep 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Sterile Urethral Latex Foley Balloon Catheters
Model / Reference
01/01/10/22/30, 01/01/15/22/60, 01/01/10/20/30, 01/01/10/14/30, 01/01/15/24/60, 01/01/10/18/30
Primary DI / UDI-DI
09555942810053, 09555942810169, 09555942810046, 09555942810015, 09555942810176, 09555942810039
Basic UDI-DI
B-09555942810053, B-09555942810169, B-09555942810046, B-09555942810015, B-09555942810176, B-09555942810039
EMDN Code
U010201, U010202
Device Class
Class IIb
Market of Registration
Denmark

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

Show properties
  • 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