gudid
Primary ID: NewTom IOS
NewTom (UDI NewTom IOS)
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 IOS
Device Regulatory Overview
The NewTom (Model/Catalog Number: NewTom IOS) is a medical device manufactured by CEFLA SOCIETA' COOPERATIVA. This product is indexed under FDA Product Code / Category Classification NOF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- NewTom IOS
- Product Code / EMDN
- NOF
- Device Name
- The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
- Database Sync Date
- 2026-08-09 09:04:34
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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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 IOS.
What classification code is assigned to this device?
This device is registered under product classification code NOF.
Similar Classification Devices (NOF)
Other Devices by CEFLA SOCIETA' COOPERATIVA
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