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Foley Balloon Catheter 2 way 22 FR (Latex)

by Sterimed Group

Ref SMD 500

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-89041941030852 Basic UDI-DI 89041941030852UDI-DIDate5 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Foley Balloon Catheter 2 way 22 FR (Latex)
Model / Reference
SMD 500
Primary DI / UDI-DI
89041941030852
Basic UDI-DI
B-89041941030852
EMDN Code
U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
Device Class
Class IIa
EU market of registration
Türkiye

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

  • 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