Identity
- Trade Name
- VX22-NP EUDAMEDVisionix FDA UDI
- Generic Name
- Visual acuity light box FDA UDI
- Device Name
- VX22 EUDAMEDChart Display FDA UDI
- Model / Reference
- VX22-NP EUDAMEDFDA UDIVX22 EUDAMED
- Description
- Chart Display FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000237 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000152LL EUDAMED
- Direct Marketing DI
- 03664188000237 EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Visual acuity light box FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1150 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
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
Category: Visual acuity light box
Visionix by Luneau Technology Operations — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- Visionix — LUNEAU TECHNOLOGY OPERATIONS · 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 9fceae75-530c-4bc2-ab3c-e8e31eb4151f 33 fields · synced Jun 20, 2026
- EUDAMED 15c19ada-8a0a-4e7a-a6d8-370cbcf1d513 61 fields · synced Jun 20, 2026