eudamed_udi
Primary ID: 08437023265000
EPI® ALPHA (UDI 08437023265000)
Manufactured by EPI ADVANCED MEDICINE S.L.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EPI® ALPHA - Primary ID 08437023265000
Device Regulatory Overview
The EPI® ALPHA (Model/Catalog Number: EPI® ALPHA) is a medical device manufactured by EPI ADVANCED MEDICINE S.L.. This product is indexed under FDA Product Code / Category Classification Z12062899 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- EPI® ALPHA
- Product Code / EMDN
- Z12062899
- Device Name
- EPI® ALPHA
- Database Sync Date
- 2026-08-09 17:20:17
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 EPI® ALPHA?
The registered manufacturer of record for EPI® ALPHA is EPI ADVANCED MEDICINE S.L..
What is the Primary UDI-DI identifier for EPI® ALPHA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08437023265000.
What classification code is assigned to this device?
This device is registered under product classification code Z12062899.
Similar Classification Devices (Z12062899)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint