Essilor Retina 800

FDA UDI

Class II (US FDA UDI)

by Essilor International

Identity

Trade Name: ESSILOR RETINA 800 FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent FDA UDI
Model / Reference: RET1IN FDA UDI
Description: Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent FDA UDI

Identifiers

Primary DI / UDI-DI: 03615020000465 FDA UDI
FDA Product Code: HKI FDA UDI
GMDN Term: Ophthalmic fundus camera FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1120 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ophthalmic fundus camera

Essilor Retina 800 by Essilor International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic fundus camera.

RetCam Portable — Natus Medical, Inc. · Class II
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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 (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Essilor International

Sources (1)

FDA UDI 29ea0850-edcb-448d-b5f3-6ad70b110340 35 fields · synced May 30, 2026