GUDIDData
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eudamed_udi Primary ID: 08033638323342

onda (UDI 08033638323342)

Manufactured by LED SpA

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for onda - Primary ID 08033638323342

Device Regulatory Overview

The onda (Model/Catalog Number: OND001) is a medical device manufactured by LED SpA. This product is indexed under FDA Product Code / Category Classification Z12139001 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
OND001
Product Code / EMDN
Z12139001
Device Name
onda
Database Sync Date
2026-08-09 16:30:28

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 onda?

The registered manufacturer of record for onda is LED SpA.

What is the Primary UDI-DI identifier for onda?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08033638323342.

What classification code is assigned to this device?

This device is registered under product classification code Z12139001.

Similar Classification Devices (Z12139001)

Other Devices by LED SpA

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