gudid Primary ID: 6285

GrandioSO 4U (UDI 6285)

Manufactured by VOCO GmbH

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

Scannable UDI-DI Representation

Device Regulatory Overview

The GrandioSO 4U (Model/Catalog Number: 6285) is a medical device manufactured by VOCO GmbH. This product is indexed under FDA Product Code / Category Classification EBF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 6285
Product Code / EMDN: EBF
Device Name: light-curing, radiopaque nano-hybrid universalcomposite, syringe 4.5g, A2
Database Sync Date: 2026-08-09 09:07:36

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 GrandioSO 4U?

The registered manufacturer of record for GrandioSO 4U is VOCO GmbH.

What is the Primary UDI-DI identifier for GrandioSO 4U?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 6285.

What classification code is assigned to this device?

This device is registered under product classification code EBF.

Similar Classification Devices (EBF)

Other Devices by VOCO GmbH

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