Hydro 3D Tip (UDI Scalp Tips)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Hydro 3D Tip (Model/Catalog Number: Scalp Tips) is a medical device manufactured by Healux Co.,Ltd. This product is indexed under FDA Product Code / Category Classification GFE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Scalp Tips
Product Code / EMDN: GFE
Device Name
Database Sync Date: 2026-08-09 09:09:06

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 Hydro 3D Tip?

The registered manufacturer of record for Hydro 3D Tip is Healux Co.,Ltd.

What is the Primary UDI-DI identifier for Hydro 3D Tip?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Scalp Tips.

What classification code is assigned to this device?

This device is registered under product classification code GFE.

Similar Classification Devices (GFE)

Other Devices by Healux Co.,Ltd

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