gudid Primary ID: THD PressKit (FL ENV)

THD PressKit (UDI THD PressKit (FL ENV))

Manufactured by THD SPA

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

Scannable UDI-DI Representation

Device Regulatory Overview

The THD PressKit (Model/Catalog Number: THD PressKit (FL ENV)) is a medical device manufactured by THD SPA. This product is indexed under FDA Product Code / Category Classification KLA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: THD PressKit (FL ENV)
Product Code / EMDN: KLA
Device Name: THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) and an anoscope (THD n-Ano) that, in combination with the THD Anopress allows a handy and safely execution of the THD Anal manometry. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress.THD n-ano is a compact and manageable anoscope with an integrated LED light, completely disposable and packed individually. The reduced diameter and the atraumatic profile make the anoscope the ideal tool for a comfortable examination for both doctor and patient.
Database Sync Date: 2026-08-09 09:04:34

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 THD PressKit?

The registered manufacturer of record for THD PressKit is THD SPA.

What is the Primary UDI-DI identifier for THD PressKit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is THD PressKit (FL ENV).

What classification code is assigned to this device?

This device is registered under product classification code KLA.

Similar Classification Devices (KLA)

Other Devices by THD SPA

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