Identity
- Trade Name
- R-EVOLUTION EUDAMEDR-Evolution TRAY COVER EUDAMED
- Device Name
- R-EVOLUTION CR WITH ENDOLASER EUDAMEDR-Evolution/R-Evo smart drapes EUDAMED
- Model / Reference
- 111012 EUDAMED191605 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308000061 EUDAMED08059308008876 EUDAMED
- Basic UDI-DI
- 8059308EQ_REV_005MF EUDAMED8059308EQ_COV_024HN EUDAMED
- EMDN Code
- Z1212020701 PHACO-EMULSIFIERS EUDAMEDT030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
R-Evolution by Optikon 2000 S.p.A. — Class IIb — 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 | 8059308EQ_REV_005MF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (2)
- EUDAMED eb694d35-ce02-465a-a60a-d8b38c17d233 61 fields · synced Jul 9, 2026
- EUDAMED e635b3a2-70d3-4937-a3e7-f6a31dd74e5e 61 fields · synced May 19, 2026