GUDIDData
eudamed_udi Primary ID: 06970614965184

Dental Unit (UDI 06970614965184)

Manufactured by Shinva Medical Instrument Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Dental Unit - Primary ID 06970614965184

Device Regulatory Overview

The Dental Unit (Model/Catalog Number: GRACE-U) is a medical device manufactured by Shinva Medical Instrument Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z12110101 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
GRACE-U
Product Code / EMDN
Z12110101
Device Name
Dental Unit
Database Sync Date
2026-08-09 16:59:43

Full Regulatory Attributes

πŸ”’ Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Dental Unit?

The registered manufacturer of record for Dental Unit is Shinva Medical Instrument Co., Ltd..

What is the Primary UDI-DI identifier for Dental Unit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970614965184.

What classification code is assigned to this device?

This device is registered under product classification code Z12110101.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint