eudamed_udi
Primary ID: 08056209010007
DILATLAX® - Balloon Dilation System (UDI 08056209010007)
Manufactured by BenCorpp Srl
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DILATLAX® - Balloon Dilation System - Primary ID 08056209010007
Device Regulatory Overview
The DILATLAX® - Balloon Dilation System (Model/Catalog Number: TLA 005-30-500) is a medical device manufactured by BenCorpp Srl. This product is indexed under FDA Product Code / Category Classification Q030399 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- TLA 005-30-500
- Product Code / EMDN
- Q030399
- Device Name
- Balloon Dilation System
- Database Sync Date
- 2026-08-09 18:03:34
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 DILATLAX® - Balloon Dilation System?
The registered manufacturer of record for DILATLAX® - Balloon Dilation System is BenCorpp Srl.
What is the Primary UDI-DI identifier for DILATLAX® - Balloon Dilation System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08056209010007.
What classification code is assigned to this device?
This device is registered under product classification code Q030399.
Similar Classification Devices (Q030399)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint