GUDIDData
gudid Primary ID: NewTom 7G

NewTom (UDI NewTom 7G)

Manufactured by CEFLA SOCIETA' COOPERATIVA

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NewTom - Primary ID NewTom 7G

Device Regulatory Overview

The NewTom (Model/Catalog Number: NewTom 7G) is a medical device manufactured by CEFLA SOCIETA' COOPERATIVA. This product is indexed under FDA Product Code / Category Classification JAK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
NewTom 7G
Product Code / EMDN
JAK
Device Name
The device NewTom 7G is a cone beam computed tomography X-ray system. It is intended for diagnostic use obtaining geometric information and radiologic density from two-dimensional and three-dimensional images of anatomic particulars and objects in the examined area.
Database Sync Date
2026-08-09 09:04:34

Full Regulatory Attributes

🔒 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 NewTom?

The registered manufacturer of record for NewTom is CEFLA SOCIETA' COOPERATIVA.

What is the Primary UDI-DI identifier for NewTom?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is NewTom 7G.

What classification code is assigned to this device?

This device is registered under product classification code JAK.

Programmatic Export

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

JSON API Endpoint