Smartpack

FDA UDI

Class II (US FDA UDI)

by Keeler Limited

Identity

Trade Name: SMARTPACK FDA UDI
Generic Name: Indirect binocular ophthalmoscope FDA UDI
Model / Reference: 1945-P-1001 FDA UDI

Identifiers

Primary DI / UDI-DI: 05055272702874 FDA UDI
FDA Product Code: HLJ FDA UDI
GMDN Term: Indirect binocular ophthalmoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indirect binocular ophthalmoscope

Smartpack by Keeler Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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HEINE OMEGA®500 — 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 II	Pending data

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Manufacturer

Manufacturer: Keeler Limited

Sources (1)

FDA UDI 731dde38-60fa-4365-8652-0dc77e692d50 32 fields · synced May 30, 2026