Supraflex Star
by Sahajanand Medical Technologies Limited 88 variants
Part of a family of 135 devices: see the family page
Ref FGTT400032Model FGTZ200008
Supraflex Star (FGTT400032) is a Class III device made by Sahajanand Medical Technologies Limited, registered in EUDAMED on 3 Aug 2022 (Basic UDI-DI B-08904118390942) with CE/MDR certificate G70 096201 0008 valid until 12 Aug 2031, active as of 25 Oct 2026.
Active
CE MDR CE MDD
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-08904118390942 08904118390942 | Date3 Aug 2022 | StatusActive |
Official records
- EUDAMED public site B-08904118390942
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-08904118390942
- 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- Withdrawn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
Specification
- Device name
- Sirolimus Eluting Coronary Stent System
- Model / reference
- FGTT400032, FGTZ200008
- Primary DI / UDI-DI
- 08904118390942
- Basic UDI-DI
- B-08904118390942, 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
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