Identity
- Trade Name
- Pack cataracte Vivalto n°1 EUDAMED
- Device Name
- Sets d'ophtalmologie EUDAMED
- Model / Reference
- 401555 EUDAMED401555-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700433500548 EUDAMED03700433505437 EUDAMED
- Basic UDI-DI
- 3666002PP-OPH-PQ EUDAMED
- EMDN Code
- Q021113 OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Sets à façon et à usage unique d'ophtalmologie destinés au traitement (injection/chirurgie) des pathologies de l’œil et de ses annexes : paupières, conjonctive, glandes lacrymales. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Pack cataracte Vivalto n°1 by Raffin Medical — Class IIa — 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 | 3666002PP-OPH-PQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Raffin Medical
- EUDAMED SRN
- FR-PR-000004621
Sources (2)
- EUDAMED 5924c220-a45d-42ac-b1ab-326e97b255d3 61 fields · synced Oct 6, 2026
- EUDAMED 9b2bff97-aff3-40bf-b2a5-e462c3d54ec3 61 fields · synced May 19, 2026