Identity
- Trade Name
- Vertical prism bar (30 dpt) EUDAMEDVisionix FDA UDI
- Generic Name
- Diagnostic ophthalmic prism FDA UDI
- Device Name
- Prisms for Optometry EUDAMED
- Model / Reference
- 8630-1612-53 EUDAMEDPrism Bar vertical FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000466 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000398MN EUDAMED
- FDA Product Code
- HKW FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Diagnostic ophthalmic prism FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1650 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: Diagnostic ophthalmic prism
Visionix by Luneau Technology Operations — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic ophthalmic prism.
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · Class I
- Optego — Optego Vision USA, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (2)
- FDA UDI 534e8288-cdad-4fa5-af83-aae5541eb598 32 fields · synced Jul 9, 2026
- EUDAMED 47c611ca-bc69-4871-b3f6-d2eeb5e3d9eb 61 fields · synced Jul 9, 2026