THE COMPANY

We are an Italian company that operates in European and extra-European markets.

The industrial activity of production of medical devices is the DNA of this Italian reality that over the years has been able to follow and anticipate the evolution of the markets, in terms of quality standards and demand for safety products for the medical world.

However, the interior of the medical commitment SBM Sistemi for product quality goes beyond the adherence of internationally recognized standards and extends in the attitude of our highly skilled production staff and the quality dedicated team, who are always aware the fact that the products they manufacture are used to save lives in critical care applications both locally and worldwide.

THE COMPANY

ID registration BD/RDN

  • I.C.P. OSA registration number at the Ministry: 1556084/R
  • I.C.P. IOL registration number at the Ministry: 1340867/R
  • I.C.P. SLIT LAMP registration number at the Ministry: 1340861/R
  • I.C.P. SLIT LAMP PLUS registration number at the Ministry: 1340862/R
  • I.C.P. TEARSCOPE registration number at the Ministry: 1340864/R
  • I.C.P. MGD registration number at the Ministry: 1392897/R
  • I.C.P. MEASUREMENT registration number at the Ministry: 1340865/R
  • I.C.P. REDFLEX registration number at the Ministry: 1705629/R
  • IDRA registration number at the Ministry: 1705624/R

and more

Fda Registration Number
: 3013488369
FEI Number*: 3013488369
Status: Active
Date Of Registration Status: 2018

Furthermore all devices are certified CE and are accordant to the European regulations in force.

Electro medical test – photo biological test – etc ISO 13485 Quality Management System for Medical Devices is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements. ISO 13485: 2016 has been harmonized against the three EU Medical Devices Directives (Medical Devices, in vitro Diagnostic Devices and Active Implantable Devices), so certification to this standard by an accredited certification body such as EMC automatically demonstrates compliance with specific clauses in these directives.

The certification of a quality management system, specifically for medical devices, to ISO 13485 is essential, for medical companies which export their products to the global market.  

In the European Union, the fulfillment of EU. Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and in vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.

INTERNATIONAL REGISTRATION

UNI EN ISO 9001:2015 Nr. 8631/0
UNI CEI EN ISO 13485:2016 Nr. 8632/0