Skip to content

Supraflex Star

by Sahajanand Medical Technologies Limited India EUDAMED

Ref FGTT250020Model FGTZ200008

EMDN P070402010301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number89041183T2CU Basic UDI-DIDate12 Aug 2026RegisteredStatusActive
European UnionCE/MDR Number89041183T2CU Basic UDI-DIDate12 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Sirolimus Eluting Coronary Stent System
Model / Reference
FGTZ200008, FGTT250020
Primary DI / UDI-DI
08904118390256
Basic UDI-DI
89041183T2CU, B-08904118390256
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
Market of Registration
Germany
Ireland

Manufacturer details

EUDAMED SRN
IN-MF-000016582
Authorised representative
Obelis s.a. BE-AR-000000106

From the manufacturer

Manufacturer's product page: Supraflex Star

Other devices from Sahajanand Medical Technologies Limited

See all devices from Sahajanand Medical Technologies Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • CMR Substance
  • Endocrine Disruptor
  • 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

Sources (2)

  • EUDAMED 08904118390256|89041183T2CU 61 fields · synced 25 Oct 2026
  • EUDAMED 08904118390256|B-08904118390256 61 fields · synced 25 Oct 2026