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Foley catheter

by Medivac Surgical Pvt Ltd India EUDAMED

Ref 19230001

EMDN U010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08908014490690 Basic UDI-DIDate20 May 2026RegisteredStatusActive

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
Foley catheter
Model / Reference
19230001
Primary DI / UDI-DI
08908014490690
Basic UDI-DI
B-08908014490690
EMDN Code
U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000051901
Authorised representative
mdi Europa GmbH DE-AR-000006218

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
  • Administering Medicine
Other properties (8)
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 6f4e4851-93cd-4d53-8d44-401c9de45910 61 fields · synced 24 Oct 2026