gudid Primary ID: 1227-2

Labtron (UDI 1227-2)

Manufactured by GF HEALTH PRODUCTS, INC.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Labtron (Model/Catalog Number: 1227-2) is a medical device manufactured by GF HEALTH PRODUCTS, INC.. This product is indexed under FDA Product Code / Category Classification HLJ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 1227-2
Product Code / EMDN: HLJ
Device Name: Standard Ophthalmoscope Set
Database Sync Date: 2026-08-09 09:14:43

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Labtron?

The registered manufacturer of record for Labtron is GF HEALTH PRODUCTS, INC..

What is the Primary UDI-DI identifier for Labtron?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1227-2.

What classification code is assigned to this device?

This device is registered under product classification code HLJ.

Similar Classification Devices (HLJ)

Other Devices by GF HEALTH PRODUCTS, INC.

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