Supraflex Star
by Sahajanand Medical Technologies Limited 88 variants
Part of a family of 135 devices: see the family page
Ref FGTT450012Model FGTZ200008
Supraflex Star (FGTT450012) is a Class III device made by Sahajanand Medical Technologies Limited, registered in EUDAMED on 12 Aug 2026 (Basic UDI-DI 89041183T2CU) with CE/MDR certificate G70 096201 0008 valid until 12 Aug 2031, active as of 23 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 | Number89041183T2CU 08904118303423 | Date12 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 89041183T2CU
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 89041183T2CU
- Certificate issued EUDAMED G70 096201 0008
- Certificate expires EUDAMED G70 096201 0008
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
EU market availability
Made available in 17 countries, as listed in EUDAMED:
- Austria since 1 Feb 2020
- Belgium since 1 Jul 2019
- Bulgaria since 1 Jul 2019
- 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 Jul 2019
- Malta since 1 Apr 2021
- 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
- FGTZ200008, FGTT450012
- Primary DI / UDI-DI
- 08904118303423
- Basic UDI-DI
- 89041183T2CU, B-08904118303423
- EMDN code
- P070402010301 Coronary drug eluting stents (des) with polymers
- Device class
- Class III
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- GermanyIreland
Manufacturer details
- EUDAMED SRN
- IN-MF-000016582
- Authorised representative
- Obelis s.a. BE-AR-000000106
From the manufacturer
Manufacturer's product page: Supraflex Star
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