gudid
Primary ID: M3
Paradigm BX (UDI M3)
Manufactured by Smarter Alloys Inc
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Paradigm BX - Primary ID M3
Device Regulatory Overview
The Paradigm BX (Model/Catalog Number: M3) is a medical device manufactured by Smarter Alloys Inc. This product is indexed under FDA Product Code / Category Classification EKS within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- M3
- Product Code / EMDN
- EKS
- Device Name
- Multi-taper NiTi rotary endodontic file, size M3, 25mm length
- Database Sync Date
- 2026-08-09 09:01:11
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 Paradigm BX?
The registered manufacturer of record for Paradigm BX is Smarter Alloys Inc.
What is the Primary UDI-DI identifier for Paradigm BX?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M3.
What classification code is assigned to this device?
This device is registered under product classification code EKS.
Similar Classification Devices (EKS)
Other Devices by Smarter Alloys Inc
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint