eudamed_udi Primary ID: 08033638325964

SURTRON LASER 8 (UDI 08033638325964)

Manufactured by LED SpA

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

Scannable UDI-DI Representation

Device Regulatory Overview

The SURTRON LASER 8 (Model/Catalog Number: LDC001) is a medical device manufactured by LED SpA. This product is indexed under FDA Product Code / Category Classification Z12011016 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: LDC001
Product Code / EMDN: Z12011016
Device Name: SURTRON LASER 8
Database Sync Date: 2026-08-09 16:51:25

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 SURTRON LASER 8?

The registered manufacturer of record for SURTRON LASER 8 is LED SpA.

What is the Primary UDI-DI identifier for SURTRON LASER 8?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08033638325964.

What classification code is assigned to this device?

This device is registered under product classification code Z12011016.

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