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Supraflex Star

by Sahajanand Medical Technologies Limited 88 variants

Ref FGTT200044Model FGTZ200008

Active European Union

CE MDR

Valid until

12 Aug 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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/MDR NumberG70 096201 0008 Date13 Aug 2026IssuedStatusActive expires 12 Aug 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sirolimus Eluting Coronary Stent System
Model / Reference
FGTZ200008, FGTT200044
Primary DI / UDI-DI
08904118390096
Basic UDI-DI
89041183T2CU, B-08904118390096
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU 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

  • 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