GUDIDData
gudid Primary ID: HDI-U20DF

HDI-P (UDI HDI-U20DF)

Manufactured by Rayence Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HDI-P - Primary ID HDI-U20DF

Device Regulatory Overview

The HDI-P (Model/Catalog Number: HDI-U20DF) is a medical device manufactured by Rayence Co., Ltd.. This product is indexed under FDA Product Code / Category Classification MUH within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
HDI-U20DF
Product Code / EMDN
MUH
Device Name
Digital Dental Intra Oral Sensor is a device which acquires digital intra-oral images. Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Database Sync Date
2026-08-09 09:28:55

Full Regulatory Attributes

🔒 Token Gated
{
    "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 HDI-P?

The registered manufacturer of record for HDI-P is Rayence Co., Ltd..

What is the Primary UDI-DI identifier for HDI-P?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is HDI-U20DF.

What classification code is assigned to this device?

This device is registered under product classification code MUH.

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