Identity
- Trade Name
- VX118 EUDAMEDVISIONIX FDA UDI
- Generic Name
- Optical pachymeter FDA UDI
- Device Name
- VX118 EUDAMEDThe VX118 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, pachymeter and retro illumination. FDA UDI
- Model / Reference
- VX118 EUDAMEDFDA UDI
- Description
- The VX118 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, pachymeter and retro illumination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188001180 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188001180LY EUDAMED
- FDA Product Code
- HKX FDA UDIHKO FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Optical pachymeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI886.1760 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automated ophthalmic refractometerOptical pachymeter
Visionix by Luneau Technology Operations — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Optical pachymeter.
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (2)
- FDA UDI 6b66459d-1d4b-44ee-963b-90d4a3b8be28 33 fields · synced Jul 9, 2026
- EUDAMED 0996d925-b63a-4543-9ba5-e7feea2935a8 61 fields · synced Jul 9, 2026