Eyer

FDA UDI

Class II (US FDA UDI)

by Phelcom Technologies

Identity

Trade Name: Eyer FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: Eyer Retinal Camera NM-STD FDA UDI
Model / Reference: Eyer NM-STD FDA UDI
Description: Eyer Retinal Camera NM-STD FDA UDI

Identifiers

Catalog Number: NM-STD FDA UDI
Primary DI / UDI-DI: 07908616100011 FDA UDI
510(k) Number: K221329 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

Eyer by Phelcom Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Phelcom Technologies

Sources (1)

FDA UDI 47465866-2da8-49fb-8273-da2e14b55a68 35 fields · synced May 29, 2026