GUDIDData
eudamed_udi Primary ID: 08051084180395

SONICA (UDI 08051084180395)

Manufactured by SOLTEC S.r.l.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SONICA - Primary ID 08051084180395

Device Regulatory Overview

The SONICA (Model/Catalog Number: 60 EP S3 SC V2) is a medical device manufactured by SOLTEC S.r.l.. This product is indexed under FDA Product Code / Category Classification Z12011302 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
60 EP S3 SC V2
Product Code / EMDN
Z12011302
Device Name
ULTRASONIC CLEANER
Database Sync Date
2026-08-09 16:45:55

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of SONICA?

The registered manufacturer of record for SONICA is SOLTEC S.r.l..

What is the Primary UDI-DI identifier for SONICA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08051084180395.

What classification code is assigned to this device?

This device is registered under product classification code Z12011302.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint