Identity
- Trade Name
- Vision-R 800+ EUDAMED
- Device Name
- VISION-R EUDAMED
- Model / Reference
- V01015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615020000700 EUDAMED
- Basic UDI-DI
- 361502000000IVISIONR000NQ EUDAMED
- EMDN Code
- Z1212012080 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Vision-R 800+ by Essilor International — Class I — 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 | 361502000000IVISIONR000NQ | Class I | Active |
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Manufacturer
- Manufacturer
- Essilor International
- EUDAMED SRN
- FR-MF-000007175
Sources (2)
- EUDAMED d802a480-87ef-4b30-a344-d109cb62f57e 61 fields · synced Jul 24, 2026
- EUDAMED 72c0c436-20bc-429b-b783-1fa9546d5141 61 fields · synced Jul 24, 2026