gudid Primary ID: K5126-00-1618-D

UniTip Catheter (UDI K5126-00-1618-D)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The UniTip Catheter (Model/Catalog Number: K5126-00-1618-D) is a medical device manufactured by Unisensor AG. This product is indexed under FDA Product Code / Category Classification FFX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: K5126-00-1618-D
Product Code / EMDN: FFX
Device Name
Database Sync Date: 2026-08-09 09:16:10

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 UniTip Catheter?

The registered manufacturer of record for UniTip Catheter is Unisensor AG.

What is the Primary UDI-DI identifier for UniTip Catheter?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is K5126-00-1618-D.

What classification code is assigned to this device?

This device is registered under product classification code FFX.

Similar Classification Devices (FFX)

Other Devices by Unisensor AG

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