LEONE SPA (UDI P3000-91)

Manufactured by LEONE SPA

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The LEONE SPA (Model/Catalog Number: P3000-91) is a medical device manufactured by LEONE SPA. This product is indexed under FDA Product Code / Category Classification EIF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: P3000-91
Product Code / EMDN: EIF
Device Name: LIP RETRACTOR KIT
Database Sync Date: 2026-08-09 09:04:35

Full Regulatory Attributes

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{
    "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 LEONE SPA?

The registered manufacturer of record for LEONE SPA is LEONE SPA.

What is the Primary UDI-DI identifier for LEONE SPA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P3000-91.

What classification code is assigned to this device?

This device is registered under product classification code EIF.

Similar Classification Devices (EIF)

Other Devices by LEONE SPA

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