gudid
Primary ID: Bio/Screen
AdDent (UDI Bio/Screen)
Manufactured by ADDENT, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AdDent - Primary ID Bio/Screen
Device Regulatory Overview
The AdDent (Model/Catalog Number: Bio/Screen) is a medical device manufactured by ADDENT, INC.. This product is indexed under FDA Product Code / Category Classification NXV within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Bio/Screen
- Product Code / EMDN
- NXV
- Device Name
- The Bio/Screen Oral Exam Light is a device intended for use as an adjunct to traditional oral examination to enhance the visualization of oral mucosal abnormalities.
- Database Sync Date
- 2026-08-09 09:03:36
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 AdDent?
The registered manufacturer of record for AdDent is ADDENT, INC..
What is the Primary UDI-DI identifier for AdDent?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Bio/Screen.
What classification code is assigned to this device?
This device is registered under product classification code NXV.
Similar Classification Devices (NXV)
Other Devices by ADDENT, INC.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint