Identity
- Trade Name
- Supraflex Cruz Nevo EUDAMED
- Device Name
- Supraflex Cruz Nevo EUDAMED
- Model / Reference
- FGTO300028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904442301508 EUDAMED
- Basic UDI-DI
- B-08904442301508 EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Supraflex Cruz Nevo by Sahajanand Medical Technologies Limited — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Supraflex Cruz
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08904442301508 | Class III | Active |
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Manufacturer
- Manufacturer
- Sahajanand Medical Technologies Limited
- EUDAMED SRN
- IN-MF-000016582
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED b4f7c86e-db14-4c2e-8119-198a07fb6d83 61 fields · synced Jun 19, 2026