SOLED15 (UDI SOLED15 /TB)

Manufactured by ACEM SPA

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

Scannable UDI-DI Representation

Device Regulatory Overview

The SOLED15 (Model/Catalog Number: SOLED15 /TB) is a medical device manufactured by ACEM SPA. This product is indexed under FDA Product Code / Category Classification KZF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: SOLED15 /TB
Product Code / EMDN: KZF
Device Name: SOLED15 TROLLEY ABPS
Database Sync Date: 2026-08-09 09:04:32

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 SOLED15?

The registered manufacturer of record for SOLED15 is ACEM SPA.

What is the Primary UDI-DI identifier for SOLED15?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SOLED15 /TB.

What classification code is assigned to this device?

This device is registered under product classification code KZF.

Similar Classification Devices (KZF)

Other Devices by ACEM SPA

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