Identity
- Trade Name
- RETINA 800 EUDAMEDESSILOR FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- RETINA 800 EUDAMEDAutomatic eye-fundus camera and software intended for photographing, displaying,and storing images of the retina without the use of a mydriatic agent. FDA UDI
- Model / Reference
- Retina 800 EUDAMEDFDA UDI
- Description
- Automatic eye-fundus camera and software intended for photographing, displaying,and storing images of the retina without the use of a mydriatic agent. FDA UDI
Identifiers
- Catalog Number
- RET1IN FDA UDI
- Primary DI / UDI-DI
- 03664188000435 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000435M3 EUDAMED
- FDA Product Code
- HKI FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 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
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: Ophthalmic fundus camera
Essilor by Luneau Technology Operations — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic fundus camera.
- RetCam Portable — Natus Medical, Inc. · Class II
- 3nethra — FORUS HEALTH PRIVATE LIMITED · Class II
- Welch Allyn — MEDIMAGING INTEGRATED SOLUTION INC. · Class II
- iCam — OPTOVUE, INC. · Class II
- RetCam 3 — Natus Medical, Inc. · Class II
- Volk Pictor VP1ANT — VOLK OPTICAL INC. · Class II
- VISUCAM 224 — Carl Zeiss Meditec AG · Class II
- NON-MYDRIATIC RETINAL CAMERA TRC-NW400 — Topcon Corp. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (2)
- FDA UDI 4354ac9c-5d8b-4390-91f7-a90c7da56f77 34 fields · synced Jun 19, 2026
- EUDAMED 756bab42-ec91-4063-b563-3beffc482233 61 fields · synced Jun 19, 2026