SERTOBEC

Primary DI

05944728007192

Basic UDI-DI Code

B-05944728007192

Reference

SERTOBEC

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Rompharm Company SRL

SERTOBEC is a sterile, viscoelastic solution of sodium hyaluronate. SERTOBEC contains 30 mg/2 ml of sodium hyaluronate with a molecular weight of 1.5 - 2.4 million daltons dissolved in physiological saline solution with the average osmolality of 335 milliosmoles, in a single-use syringe. The sodium hyaluronate is purified from the bacterial fermentation of a Streptococcus strain. Each milliliter of SERTOBEC contains 15 mg of sodium hyaluronate, sodium chloride and water for injections. Sterile by moist heat.

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