Identity
- Trade Name
- VISION-R 700 EUDAMEDFDA UDI
- Generic Name
- Phoropter, electric FDA UDI
- Device Name
- VISION-R EUDAMEDVision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability FDA UDI
- Model / Reference
- V01114 EUDAMEDFDA UDI
- Description
- Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03615020000724 EUDAMEDFDA UDI
- Basic UDI-DI
- 361502000000IVISIONR000NQ 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 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-R 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 | 361502000000IVISIONR000NQ | 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 bbbc1f33-b733-420b-9a7c-11bd9174d48e 61 fields · synced Jun 18, 2026
- FDA UDI f2142127-5004-4881-8c7b-33df1409f07f 35 fields · synced May 30, 2026
- EUDAMED 52a46653-47e2-40e7-bdb8-57e275655a35 61 fields · synced Jun 18, 2026