Device
EIDON UWF Module an optional accessory for EIDON, EIDON AF and EIDON FA (EIDON Family devices) and it is compatible with all the EIDON Family devices exam modalities. The intended...
Manufacturer
CENTERVUE SPA
CENTERVUE SPA
Model: EIDON UWF Module
Catalog: AXWFLME001
DI: 08053677040123
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
EIDON UWF Module an optional accessory for EIDON, EIDON AF and EIDON FA (EIDON Family devices) and it is compatible with all the EIDON Family devices exam modalities. The intended purpose of the device is to extend the field of view of EIDON, EIDON AF and EIDON FA from 60° to 80°.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0ba791f2-3eb0-464c-aad3-ece96e22ce14
Distribution Status:
In Commercial Distribution
DUNS Number:
338702316
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08053677040123
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 10551
Name: Ophthalmic fundus camera
Definition:
An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.
FDA Product Codes
MYC
Ophthalmoscope, Laser, Scanning
Premarket Submissions
Submission Number:
K211328
Supplement Number:
000