Identity
- Trade Name
- VISION-C 600 EUDAMEDFDA UDI
- Generic Name
- Visual acuity light box FDA UDI
- Device Name
- VISION-C EUDAMEDVision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel. FDA UDI
- Model / Reference
- VRS001 EUDAMEDFDA UDI
- Description
- Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03615020000670 EUDAMEDFDA UDI
- Basic UDI-DI
- 361502000000IVISIONC000KF EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Z1212012080 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Visual acuity light box FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1150 FDA UDI
- Market of Registration
- Austria EUDAMEDFrance EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vision-C 600 by Essilor International — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 361502000000IVISIONC000KF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Essilor International
- EUDAMED SRN
- FR-MF-000007175
Sources (3)
- EUDAMED 4a666521-2961-4909-81e8-fd7a177f1671 61 fields · synced Jun 18, 2026
- FDA UDI 716bddf7-d3b6-42d9-8fd5-6048eee1363e 35 fields · synced May 30, 2026
- EUDAMED 85c18c8e-64b6-4d3f-9f9a-1280016cc75b 61 fields · synced Jun 18, 2026