Novoglan Non Surgical Phimosis Treatment

Primary DI

00860009967205

Basic UDI-DI Code

00860009967205GA

Reference

NFTE20221

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Platigo Solutions Pty Limited

A collection of devices intended to be operated by a patient at home to stretch the foreskin of the penis to treat phimosis (tightening of the foreskin) or to preferentially develop a looser foreskin. It consists of a balloon assembly, an inflator, cotton buds, insertion rods, and cleansing swabs. The inflatable balloon is inserted through the natural opening of the foreskin and positioned between the glans penis and the foreskin and inflated. This procedure is typically performed daily for a period (e.g., 14 days) to gradually stretch the foreskin. This is a single-patient device reapplied to the patient over a short term (single-use) before being discarded.

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