Amico Diagnostic Station

FDA UDI

Class I (US FDA UDI)

by Amico Diagnostic Incorporated

Identity

Trade Name: Amico Diagnostic Station FDA UDI
Generic Name: Direct ophthalmoscope FDA UDI
Device Name: Diagnostic Station -Oph & Oto LED, Spec. Dispenser with Fairfield Rail Mounts Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) FDA UDI
Model / Reference: DS-UF1-CLFL-DXX FDA UDI
Description: Diagnostic Station -Oph & Oto LED, Spec. Dispenser with Fairfield Rail Mounts Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) FDA UDI

Identifiers

Primary DI / UDI-DI: 00697077001995 FDA UDI
FDA Product Code: ERA FDA UDI
HLI FDA UDI
GMDN Term: Direct ophthalmoscope FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4770 FDA UDI
886.1570 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: Direct ophthalmoscope

Amico Diagnostic Station by Amico Diagnostic Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Direct ophthalmoscope.

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HEINE EN 100® Diagnostic Center — Heine Optotechnik GmbH & Co. KG · Class II
HEINE mini 3000® LED F.O. Diagnostic Set — Heine Optotechnik GmbH & Co. KG · Class II
JEDMED — JEDMED Instrument Company · Class II
HEINE BETA® 200 LED Ophthalmoscope — Heine Optotechnik GmbH & Co. KG · Class II
HEINE BETA® 200 Desk Set — Heine Optotechnik GmbH & Co. KG · 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 I	Pending data

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Manufacturer

Manufacturer: Amico Diagnostic Incorporated

Sources (1)

FDA UDI 94cec843-4663-46d6-a6d9-7895922991b3 34 fields · synced Jun 1, 2026