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100% Silicone Foley Balloon Catheter 2-Way

by Sterimed Group

Ref SMD 517 BH / SMD 517Model SMD 517 BH

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-89042427007542 Basic UDI-DI Date29 Dec 2025RegisteredStatusActive

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  • Withdrawn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
100% Silicone Foley Balloon Catheter 2-Way
Model / Reference
SMD 517 BH, SMD 517 BH / SMD 517
Primary DI / UDI-DI
89042427007542, 89042427007092
Basic UDI-DI
B-89042427007542, B-89042427007092
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

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No