GUDIDData
eudamed_udi Primary ID: 05056097369051

ENTERPRISE 8000X (UDI 05056097369051)

Manufactured by ArjoHuntleigh AB

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ENTERPRISE 8000X - Primary ID 05056097369051

Device Regulatory Overview

The ENTERPRISE 8000X (Model/Catalog Number: 8X23OM113DEDAA) is a medical device manufactured by ArjoHuntleigh AB. This product is indexed under FDA Product Code / Category Classification V08060103 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
8X23OM113DEDAA
Product Code / EMDN
V08060103
Device Name
ENTERPRISE 8000X
Database Sync Date
2026-08-09 16:28:56

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of ENTERPRISE 8000X?

The registered manufacturer of record for ENTERPRISE 8000X is ArjoHuntleigh AB.

What is the Primary UDI-DI identifier for ENTERPRISE 8000X?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05056097369051.

What classification code is assigned to this device?

This device is registered under product classification code V08060103.

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