Identity
- Trade Name
- Supraflex Cruz Maxim EUDAMED
- Device Name
- Supraflex Cruz Maxim EUDAMED
- Model / Reference
- FGTM200036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904442321087 EUDAMED
- Basic UDI-DI
- B-08904442321087 EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Supraflex Cruz Maxim 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-08904442321087 | 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 2fb6194b-b2e1-4a73-8e53-b3d504e7de54 61 fields · synced Aug 1, 2026