GUDIDData
gudid Primary ID: 11-1223

Vatech Clismile (UDI 11-1223)

Manufactured by Rayence Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Vatech Clismile - Primary ID 11-1223

Device Regulatory Overview

The Vatech Clismile (Model/Catalog Number: 11-1223) is a medical device manufactured by Rayence Co., Ltd.. This product is indexed under FDA Product Code / Category Classification NJM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
11-1223
Product Code / EMDN
NJM
Device Name
This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
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 Vatech Clismile?

The registered manufacturer of record for Vatech Clismile is Rayence Co., Ltd..

What is the Primary UDI-DI identifier for Vatech Clismile?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 11-1223.

What classification code is assigned to this device?

This device is registered under product classification code NJM.

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