gudid Primary ID: OS GOLDY

OPERA SYSTEM (UDI OS GOLDY)

Manufactured by Shining 3D Tech Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The OPERA SYSTEM (Model/Catalog Number: OS GOLDY) is a medical device manufactured by Shining 3D Tech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification NOF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: OS GOLDY
Product Code / EMDN: NOF
Device Name: The scanner is used to scan and capture the 3D characteristics of dental models including plaster models and impressions. It can work with the supplied software to export the 3D scan data for CAD/CAM. the scan data can be apply for the orthodontic, restoration and implant.
Database Sync Date: 2026-08-09 09:05:22

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 OPERA SYSTEM?

The registered manufacturer of record for OPERA SYSTEM is Shining 3D Tech Co., Ltd..

What is the Primary UDI-DI identifier for OPERA SYSTEM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OS GOLDY.

What classification code is assigned to this device?

This device is registered under product classification code NOF.

Similar Classification Devices (NOF)

Other Devices by Shining 3D Tech Co., Ltd.

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