Supraflex Star
by Sahajanand Medical Technologies Limited 88 variants
Part of a family of 135 devices: see the family page
Ref FGTT450044Model FGTZ200008
Supraflex Star (FGTT450044) is a Class III device made by Sahajanand Medical Technologies Limited, registered in EUDAMED on 3 Aug 2022 (Basic UDI-DI B-08904118303508) with CE/MDR certificate G70 096201 0008 valid until 12 Aug 2031, active as of 24 Oct 2026.
Active
Valid until
12 Aug 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberG70 096201 0008 | Date13 Aug 2026 | StatusActive |
| European Union | CE/MDD | NumberB-08904118303508 08904118303508 | Date3 Aug 2022 | StatusActive |
Official records
- EUDAMED public site B-08904118303508
Certificates
- G70 096201 0008 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 13 Aug 2026
- Expires
- 12 Aug 2031
Timeline
- Registered EUDAMED B-08904118303508
- Certificate issued EUDAMED G70 096201 0008
- Certificate expires EUDAMED G70 096201 0008
Coverage
- 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- Withdrawn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:
- 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
Specification
- Device name
- Sirolimus Eluting Coronary Stent System
- Model / reference
- FGTT450044, FGTZ200008
- Primary DI / UDI-DI
- 08904118303508
- Basic UDI-DI
- B-08904118303508, 89041183T2CU
- EMDN code
- P070402010301 Coronary drug eluting stents (des) with polymers
- Device class
- Class III
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- IrelandGermany
Manufacturer details
- EUDAMED SRN
- IN-MF-000016582
- Authorised representative
- Obelis s.a. BE-AR-000000106
From the manufacturer
Manufacturer's product page: Supraflex Star
Similar devices in this category
Other devices filed under CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS.
- Cobalt-chromium sirolimus eluting coronary bifurcation stent BIOSS LIM C with delivery system, Rapid Exchange ZSTB3.00X3.50X1914CS by Balton Sp. z o.o.
- Firehawk Liberty Rapamycin Target Eluting Coronary Stent System FR4023 by Shanghai MicroPort Medical (Group) Co., Ltd.
- BioMime ™ 4O BIF45044 by Meril Life Sciences Pvt. Ltd.
- Biomime™ BIO227529 by Meril Life Sciences Pvt. Ltd.
- eucaLimus ELM22513 by eucatech AG
- FirehawkTM Liberty Rapamycin Target Eluting Coronary Stent System FR3518 by Shanghai MicroPort Medical (Group) Co., Ltd.
- Cobalt-chromium sirolimus eluting coronary bifurcation stent BIOSS LIM C with delivery system, Rapid Exchange ZSTB2.75X3.50X1514CS by Balton Sp. z o.o.
- Supraflex Star FGTT450024IE by Sahajanand Medical Technologies Ireland Limited
- Combo Plus 235-382-11 by OrbusNeich Medical, B.V.
Other devices from Sahajanand Medical Technologies Limited
See all devices from Sahajanand Medical Technologies Limited →