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Stenoflex

by Kamal Encon Industries Limited 160 variants

Ref SF30036

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-89043505005122 Basic UDI-DI 89043505005122UDI-DIDate17 Jul 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  • Withdrawn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
Stenoflex - Sirolimus Eluting Coronary Stent System
Model / Reference
SF30036
Primary DI / UDI-DI
89043505005122
Basic UDI-DI
B-89043505005122
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
IN-MF-000014458
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Kamal Encon Industries Limited

See all devices from Kamal Encon Industries Limited →

Properties

  • Sterile
  • Implantable
  • Administering Medicine
  • Incorporates Medicinal Product

Other properties (7)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No