GUDIDData
eudamed_udi Primary ID: 05051968043634

SMARTSIGNS (UDI 05051968043634)

Manufactured by ArjoHuntleigh AB

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SMARTSIGNS - Primary ID 05051968043634

Device Regulatory Overview

The SMARTSIGNS (Model/Catalog Number: SC500 NTE) is a medical device manufactured by ArjoHuntleigh AB. This product is indexed under FDA Product Code / Category Classification Z1203020280 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SC500 NTE
Product Code / EMDN
Z1203020280
Device Name
SC300 SPOT MONITOR
Database Sync Date
2026-08-09 16:29:13

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 SMARTSIGNS?

The registered manufacturer of record for SMARTSIGNS is ArjoHuntleigh AB.

What is the Primary UDI-DI identifier for SMARTSIGNS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05051968043634.

What classification code is assigned to this device?

This device is registered under product classification code Z1203020280.

Programmatic Export

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

JSON API Endpoint