gudid Primary ID: HY-50021

HYGITECH (UDI HY-50021)

Manufactured by HYGITECH

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

Scannable UDI-DI Representation

Device Regulatory Overview

The HYGITECH (Model/Catalog Number: HY-50021) is a medical device manufactured by HYGITECH. This product is indexed under FDA Product Code / Category Classification FXP within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: HY-50021
Product Code / EMDN: FXP
Device Name: HYGITECH's newest overshoes are not only waterproof but economically packaged in 250 pairs. They protect the shoes of the dentists as well as the patients thanks to their impermeability. They also help to avoid all types of contaminations. Characteristics:-Waterproof-Unique Size 15x40-500 in a pack (250 pairs)-Non sterile, Single use-Blue
Database Sync Date: 2026-08-09 09:26:35

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 HYGITECH?

The registered manufacturer of record for HYGITECH is HYGITECH.

What is the Primary UDI-DI identifier for HYGITECH?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is HY-50021.

What classification code is assigned to this device?

This device is registered under product classification code FXP.

Similar Classification Devices (FXP)

Other Devices by HYGITECH

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