Develops and markets Bentrio, a drug-free barrier nasal spray based on natural bentonite.

Altamira Medica AG

Basel (CH) · Frankfurt am Main (DE, EU representative)New on Amplifa

Basel-StadtCommercial register

Public limited company (AG)Legal form

Class IIa (EU MDR)Product class

Up to 4 hours per doseDuration of effect

About Altamira Medica

Altamira Medica AG is a Swiss medical technology company headquartered in Basel. The company develops and markets Bentrio, a drug-free barrier nasal spray against allergens such as grass pollen, house dust mites and animal dander. The thixotropic spray gel forms a thin gel film of natural bentonite on the nasal mucosa, whose negatively charged layers electrostatically bind inhaled particles before they reach the immune system; the effect is immediate and lasts up to four hours. Bentrio is a CE-marked Class IIa medical device under EU MDR 2017/745 and is supervised by Notified Body 2797. Clinical efficacy has been demonstrated, among other things, in the randomised NASAR study. The product is available without prescription, contains no preservatives, and is suitable from age six as well as during pregnancy and breastfeeding. Johner Medical GmbH in Frankfurt am Main has been appointed as EU representative for GDPR and EU enquiries.

Site: Basel
Processes: Medical device (Bentrio allergen barrier nasal spray), Quality & vigilance support, Medical-scientific information for healthcare professionals
Materials: Bentonite
Certificates: CE marking medical device Class IIa (EU MDR 2017/745), CE marking Class IIa (EU MDR 2017/745)
Industries: Medical technology, Allergy/respiratory therapy, Consumer Healthcare

01
Product development
02
Formulation & manufacturing
03
Regulatory compliance (CE, EU MDR)
04
Medical device distribution
05
Quality & vigilance
06
Medical-scientific information

Active Ingredients & Formulation

Bentonite

Natural mineral with negatively charged layers that electrostatically binds allergens and moisturises the nasal mucosa.

Locations

Basel

Headquarters

Frankfurt am Main

EU representative (GDPR/EU enquiries), Johner Medical GmbH

Industries

Medical technologyAllergy/respiratory therapyConsumer Healthcare

Additional services

Medical device (Bentrio allergen barrier nasal spray)Quality & vigilance supportMedical-scientific information for healthcare professionals

Quality & Regulatory Affairs

Bentrio is a CE-marked Class IIa medical device under Regulation (EU) 2017/745 (EU MDR) with Notified Body 2797. Product complaints, vigilance reports and quality issues are handled via a dedicated quality & vigilance contact point.

Evidence	Basel
CE marking Class IIa (EU MDR 2017/745)

History

Bentrio was developed in Switzerland; its clinical efficacy has been demonstrated, among other things, in the randomised NASAR study.