gudid
Primary ID: Aoralscan 2
LARGEV (UDI Aoralscan 2)
Manufactured by Shining 3D Tech Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for LARGEV - Primary ID Aoralscan 2
Device Regulatory Overview
The LARGEV (Model/Catalog Number: Aoralscan 2) 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
- Aoralscan 2
- Product Code / EMDN
- NOF
- Device Name
- The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
- Database Sync Date
- 2026-08-09 09:05:22
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of LARGEV?
The registered manufacturer of record for LARGEV is Shining 3D Tech Co., Ltd..
What is the Primary UDI-DI identifier for LARGEV?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Aoralscan 2.
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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