gudid
Primary ID: 25750
AlphaCleanse (UDI 25750)
Manufactured by Bionix, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AlphaCleanse - Primary ID 25750
Device Regulatory Overview
The AlphaCleanse (Model/Catalog Number: 25750) is a medical device manufactured by Bionix, LLC. This product is indexed under FDA Product Code / Category Classification FQH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 25750
- Product Code / EMDN
- FQH
- Device Name
- Sample, AlphaCleanse Antimicrobial Wound Care System
- Database Sync Date
- 2026-08-09 09:04:11
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 AlphaCleanse?
The registered manufacturer of record for AlphaCleanse is Bionix, LLC.
What is the Primary UDI-DI identifier for AlphaCleanse?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 25750.
What classification code is assigned to this device?
This device is registered under product classification code FQH.
Similar Classification Devices (FQH)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint