Identity
- Trade Name
- VACUSERA EUDAMED
- Device Name
- VACUSERA EXERA REGENERATIVE KIT EUDAMED
- Model / Reference
- 238406 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M7122384061B EUDAMED
- Basic UDI-DI
- ++M712EXREJBK EUDAMED
- EMDN Code
- B010202 PLATELETS CONCENTRATE TRANSFER BAGS AND KITS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- Exera Regenerative Kit is a versatile topical regenerative formulation developed to support tissue regeneration and cellular repair across different clinical fields EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Vacusera by Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M712EXREJBK | Class III | Active |
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Manufacturer
- Manufacturer
- Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-PR-000050420
Sources (1)
- EUDAMED 9d0dbfe0-b48f-4b0c-82d3-9a105362c104 61 fields · synced Jun 19, 2026