Identity
- Trade Name
- VISION-S 700 EUDAMEDFDA UDI
- Generic Name
- Phoropter, electric FDA UDI
- Device Name
- VISION-S EUDAMEDVision-S 700 is a Compact Refraction System used to determine the refractive error and binocular FDA UDI
- Model / Reference
- VS01012 EUDAMEDFDA UDI
- Description
- Vision-S 700 is a Compact Refraction System used to determine the refractive error and binocular FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03615020000687 EUDAMEDFDA UDI
- Basic UDI-DI
- 361502000000IVISIONS000NX EUDAMED
- FDA Product Code
- HKN FDA UDI
- EMDN Code
- Z1212012080 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Phoropter, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1770 FDA UDI
- Market of Registration
- Austria 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-S 700 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 | 361502000000IVISIONS000NX | 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 (2)
- EUDAMED 57e711f1-25b3-4279-a8fa-eed57060618c 61 fields · synced Jun 18, 2026
- FDA UDI 1fe64028-4235-4e6d-96cd-b77361101e41 35 fields · synced May 30, 2026