GUDIDData
gudid Primary ID: 120000107

5CWL (UDI 120000107)

Manufactured by ESAOTE SPA

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for 5CWL - Primary ID 120000107

Device Regulatory Overview

The 5CWL (Model/Catalog Number: 120000107) is a medical device manufactured by ESAOTE SPA. This product is indexed under FDA Product Code / Category Classification ITX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
120000107
Product Code / EMDN
ITX
Device Name
Database Sync Date
2026-08-09 09:04:29

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 5CWL?

The registered manufacturer of record for 5CWL is ESAOTE SPA.

What is the Primary UDI-DI identifier for 5CWL?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 120000107.

What classification code is assigned to this device?

This device is registered under product classification code ITX.

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