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Foley Balloon Catheter 2 way 20 FR (Latex)

by Sterimed Group India EUDAMED

Ref SMD 500

EMDN U010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-89041941003122 Basic UDI-DIDate24 Jan 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 22 Oct 2026

Device Name
Foley Balloon Catheter 2 way 20 FR (Latex)
Foley Balloon Catheter 2 way - 20 FR
Model / Reference
SMD 500
Primary DI / UDI-DI
89041941003122, 89041941226668
Basic UDI-DI
B-89041941003122, B-89041941226668
EMDN Code
U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
Device Class
Class IIa
Market of Registration
Türkiye
Romania

Manufacturer details

EUDAMED SRN
IN-MF-000032688
Authorised representative
Obelis s.a. BE-AR-000000106

From the manufacturer

Manufacturer's product page: Foley Balloon Catheter

Other devices from Sterimed Group

See all devices from Sterimed Group →

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 539f225a-89d6-42b4-8ffc-cd0f0a28af14 61 fields · synced 22 Oct 2026
  • EUDAMED 78395024-5220-459f-83e5-0f52d2b220ba 61 fields · synced 18 May 2026