Identity
- Trade Name
- VX65 EUDAMEDVISIONIX FDA UDI
- Generic Name
- Phoropter, electric FDA UDI
- Device Name
- VX65 EUDAMEDThe VX65 is an automatic phoropter, to measure the subjective refraction, it is used as an ophthalmic device. FDA UDI
- Model / Reference
- VX65 EUDAMEDFDA UDI
- Description
- The VX65 is an automatic phoropter, to measure the subjective refraction, it is used as an ophthalmic device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000077 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000077LX EUDAMED
- Direct Marketing DI
- 03664188000077 EUDAMED
- FDA Product Code
- HKN FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Phoropter, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1770 FDA UDI
- Market of Registration
- France 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
Yes
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
Category: Phoropter, electric
Visionix by Luneau Technology Operations — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Phoropter, electric.
- Vision-R 700 — ESSILOR INTERNATIONAL · Class I
- SightChek Digital Phoropter — REICHERT INC. · Class I
- SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000 — Topcon Corp. · Class I
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- Advancing Eyecare — Lombart Brothers, Inc. · Class I
- COMPU VISION CV-5000 — Topcon Corp. · Class I
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class I
- YEASN — Chongqing Yeasn Science & Technology Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (2)
- FDA UDI 058131a7-af21-433c-9391-97e6bb043a50 33 fields · synced Jun 18, 2026
- EUDAMED 377f0476-fe06-4820-a088-81f6e831eead 61 fields · synced Jun 18, 2026