Supraflex Cruz
by Sahajanand Medical Technologies Limited 43 variants
Ref FGTZ300040Model FGTZ200008
Active
CE MDR CE MDD
Valid until
12 Aug 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberG70 096201 0008 | Date13 Aug 2026 | StatusActive |
| European Union | CE/MDD | NumberB-08904118388529 08904118388529 | Date12 Jul 2022 | StatusActive |
Certificates
- G70 096201 0008 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 13 Aug 2026
- Expires
- 12 Aug 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- Sirolimus Eluting Coronary Stent System
- Model / Reference
- FGTZ300040, FGTZ200008
- Primary DI / UDI-DI
- 08904118388529
- Basic UDI-DI
- B-08904118388529, 89041183T2CU
- EMDN Code
- P070402010301 Coronary drug eluting stents (des) with polymers
- Device Class
- Class III
- 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 Cruz
Other devices from Sahajanand Medical Technologies Limited
See all devices from Sahajanand Medical Technologies Limited →
Properties
Other properties (7)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Measuring Function: No