Identity
- Device Name
- KIT ALCON SIN SYSTANE EUDAMED
- Model / Reference
- 055374 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435260900005 EUDAMED
- Basic UDI-DI
- 84352609055374TU EUDAMED
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- KIT POSTOPERATORIO OFTALMOLÓGICO QUE INCLUYE TODOS LOS ELEMENTOS NECESARIOS PARA EL CUIDADO DEL OJO INTERVENIDO EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Surgical retractor/retraction system blade, single-use
Kit Alcon Sin Systane by Mape Asesores, S.a.u. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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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 | 84352609055374TU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mape Asesores, S.a.u.
- EUDAMED SRN
- ES-PR-000014607
Sources (1)
- EUDAMED be69a710-366f-4d50-b889-674abd20453e 61 fields · synced Jul 15, 2026