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Supraflex Star

by Sahajanand Medical Technologies Limited 88 variants

Ref FGTT350032Model FGTZ200008

Active European Union

CE MDR CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberG70 096201 0008 Date13 Aug 2026IssuedStatusActive expires 12 Aug 2031
European UnionCE/MDD NumberB-08904118390720 Basic UDI-DI 08904118390720UDI-DIDate3 Aug 2022RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

FinlandLatviaLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumCzech RepublicSlovakiaAustriaHungaryRomaniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

EU market availability

Made available in 23 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 1 Feb 2020
  • Belgium since 1 Jul 2019
  • Bulgaria since 1 Jul 2019
  • Croatia since 1 Jul 2019
  • Cyprus since 1 Apr 2021
  • Czechia since 1 Jul 2019
  • Finland since 1 Apr 2020
  • France since 1 Jul 2019
  • Germany since 1 Jul 2019
  • Greece since 1 Jul 2019
  • Hungary since 1 Jul 2019
  • Ireland since 1 Jul 2019
  • Italy since 1 Apr 2021
  • Latvia since 1 Jul 2019
  • Lithuania since 1 Jul 2019
  • Malta since 1 Jul 2022
  • Netherlands since 1 Nov 2019
  • Poland since 1 Jul 2019
  • Portugal since 1 Jul 2019
  • Romania since 1 Jul 2019
  • Slovakia since 1 Sep 2019
  • Spain since 1 Sep 2019
  • Türkiye since 1 Aug 2019

Last checked 30 Oct 2026.

Specification

EUDAMED

Device Name
Sirolimus Eluting Coronary Stent System
Model / Reference
FGTT350032, FGTZ200008
Primary DI / UDI-DI
08904118390720
Basic UDI-DI
B-08904118390720, 89041183T2CU
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU market of registration
Ireland
Germany

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