Identity
- Trade Name
- VX120 EUDAMEDVISIONIX FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- VX120 EUDAMEDThe VX120 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, tonometer, pachymeter and retro illumination. FDA UDI
- Model / Reference
- VX120 EUDAMEDFDA UDI
- Description
- The VX120 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, tonometer, pachymeter and retro illumination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188001203 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188001203LK EUDAMED
- Direct Marketing DI
- 03664188001203 EUDAMED
- FDA Product Code
- HKX FDA UDIHKO FDA UDIMXK FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI886.1760 FDA UDI886.1850 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Automated ophthalmic refractometerOphthalmic tonometer, battery-operatedOptical 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
MDR
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 b3809afb-b957-4114-a16b-594f016bcd98 33 fields · synced Jul 10, 2026
- EUDAMED 45d55340-8f72-4493-bfc7-0725aaab06fe 61 fields · synced Jul 10, 2026