GUDIDData
gudid Primary ID: Monolayer

Flexible Block (UDI Monolayer)

Manufactured by SHANDONG HUGE DENTAL MATERIAL CORPORATION

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

Device Regulatory Overview

The Flexible Block (Model/Catalog Number: Monolayer) is a medical device manufactured by SHANDONG HUGE DENTAL MATERIAL CORPORATION. This product is indexed under FDA Product Code / Category Classification EBI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Monolayer
Product Code / EMDN
EBI
Device Name
Database Sync Date
2026-08-09 09:06:47

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 Flexible Block?

The registered manufacturer of record for Flexible Block is SHANDONG HUGE DENTAL MATERIAL CORPORATION.

What is the Primary UDI-DI identifier for Flexible Block?

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

What classification code is assigned to this device?

This device is registered under product classification code EBI.

Programmatic Export

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

JSON API Endpoint