GUDIDData
gudid Primary ID: THD 4K CAM

THD Procto Software System (UDI THD 4K CAM)

Manufactured by THD SPA

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for THD Procto Software System - Primary ID THD 4K CAM

Device Regulatory Overview

The THD Procto Software System (Model/Catalog Number: THD 4K CAM) is a medical device manufactured by THD SPA. This product is indexed under FDA Product Code / Category Classification IYO within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
THD 4K CAM
Product Code / EMDN
IYO
Device Name
THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution using THD's diagnostic and surgical devices, equipped with a special mechanical connection interface and septic protection sleeve.Capture is done using the THD ProctoSoftware interface, a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera.
Database Sync Date
2026-08-09 09:21:50

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 THD Procto Software System?

The registered manufacturer of record for THD Procto Software System is THD SPA.

What is the Primary UDI-DI identifier for THD Procto Software System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is THD 4K CAM.

What classification code is assigned to this device?

This device is registered under product classification code IYO.

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