Singderm

Primary DI

06936020114615

Basic UDI-DI Code

B-06936020114615

Reference

DF-SD-24-1.0

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Hangzhou Singclean Medical Products Co., Ltd.

Singderm® is a sterile, biodegradable, nonpyrogenic, viscoelastic, clear, colorless, homogenized gel implant. It consists of modifiedl hyaluronic acid (HA) produced by bacteria, formulated to a concentration of 24 mg/ml and 0.3% lidocaine in a physiologic buffer. Singderm is presented in a graduated, pre-filled, disposable syringe. Each box contains one syringe, an instruction leaflet and a set of labels in order to ensure traceability. The contents of the Singderm syringe are sterilized by moist heat. If presense, the needles arel sterilized by radiation or ethylene oxide.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).