Statut STÉRIMAR ® : dispositifs médicaux de classe II A

The following products STERIMAR :

  • STÉRIMAR ® « Nasal hygiene »
  • STÉRIMAR ® baby
  • STÉRIMAR ® « Blocked nose »
  • STÉRIMAR ® Copper
  • STÉRIMAR ® Manganese
  • STÉRIMAR ® Sulphur

are class IIA medical devices (in accordance with article L5211-1 of the Public Health Code and EEC Directive 93/42).

By virtue of which, STÉRIMAR enjoys mandatory CE marking, the notified body G-MED No. 0459 having participated in the procedures evaluating product compliance with audit of annual monitoring of production sites.


STÉRIMAR ® sea water product

The sea water used in STÉRIMAR is collected in deep water, after checking for purity. The actual collection site is selected according to weather conditions and studies of ocean currents.

Our suppliers have undertaken to guarantee the quality of sea water supplied and to comply scrupulously with the collection site and collection process specified. Water is collected from an area where coastal waters are subject to regular monitoring by official bodies with the authority to issue a rapid alert in the event of any health risk.

On reception at the production plant, the sea water is once again subjected to chemical and bacteriological testing.

STÉRIMAR ® packaging

STÉRIMAR solution is contained in a sterile valve-bag, completely isolated from the propellant gas and the walls of the aluminium can.

Being under pressure, STÉRIMAR can be used in any position until no solution remains.

STÉRIMAR has the most advanced spray system :

The technology combining a valve-bag and a special nozzle produces gentle microdiffusion into the nasal fossae, in complete safety.

Stérimar valve-bag system
Valve-bag before (folded)
and after (inflated)

1) The valve-bag system :

Is a modern production process based on isolating the product from the propellant gas.
The solution is injected into an airtight bag sterilised by irradiation, previously placed inside a laquered aluminium can and sealed with a continuous function valve.
The nozzle is fitted on the valve and the protective cap is put on to protect the nozzle and close the can.
The can is filled with nitrogen, an inert gas which exerts continuous pressure on the bag, thereby delivering a fine aerosol when the nozzle is pressed.

The valve-bag system has several advantages :

  • bacteriological safety, since the pressurised bag prevents bacteria from entering;
  • complete use of all the product until no solution remains;
  • no contact of product with the propellant gas;
  • easy to use, particularly in children, since the product can be sprayed in any position.

Assembly of STÉRIMAR sea water spray

Assembly of Sterimar

  1. insertion of valve-bag
  2. introduction of propellant gas into can, which is then sealed
  3. injection of solution and assembly of nozzle
  4. protective cap put on
  5. validation of the quality of the spray (many different inspection tests)
STERIMAR Nozzles

2) STÉRIMAR nozzles :

The exclusive STÉRIMAR® nozzle was specially designed in 1995 to suit ALL nostril sizes. Its flared shape makes it self-blocking.

The diffuser mounted in the STÉRIMAR® nozzle ensures a unique form of microdiffusion. Each parameter (shape, size, droplet dispersal cone) has been rigorously tested.

STÉRIMAR can be used with complete safety on babies, children and adults. (Tests organised by the National Test Laboratory – Laboratoire National d’Essai LNE GMED).

Embout bébé STÉRIMAR


STÉRIMAR Baby nozzle

The baby nozzle diffuses a gently spray
and has a safety flange to avoid injury to baby’s nose.


STÉRIMAR is environment-friendly : its aluminium can is recyclable. The outer box is made from recycled cardboard and the information leaflet is printed on chlorine-free ecological paper.