Skip to content

GENOSS DES Sirolimus Eluting Coronary Stent System

by GENOSS Co., Ltd. 69 variants

Ref GDES-38-350

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-08809324769325 Basic UDI-DI 08809324769325UDI-DIDate1 Oct 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  • Withdrawn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

Model / Reference
GDES-38-350
Primary DI / UDI-DI
08809324769325
Basic UDI-DI
B-08809324769325
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU market of registration
Estonia

Manufacturer details

EUDAMED SRN
KR-MF-000029064
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Genoss

See all devices from Genoss →

Properties

  • Sterile
  • Implantable
  • Incorporates Medicinal Product

Other properties (8)

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