Enema Kit

Primary DI

05065007341087

Basic UDI-DI Code

5065007341EnemaKitWE

Reference

EK-2024-A001

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

T2 Corporation Limited

A device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis. The device consists of a hand-held fluid reservoir (e.g., bottle, bulb) with a nozzle from which an enema solution is intended to be administered by squeezing the filled reservoir following insertion of the nozzle into the rectum; it may be prefilled with a non-medicated enema solution. It is intended for use in the home or healthcare facility. This is a reusable device intended to be sterilized prior to use.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).