Safety & Quality
BEMER is a certified, licensed medical device.
BEMER Physical Vascular Therapy devices meet rigorous international standards for medical device safety, quality, and efficacy. In South Africa, they are registered and licensed for sale by the Department of Health.
Licensed for sale in South Africa.
BEMER Systems are registered and licensed by the South African Department of Health as Class 2a medical devices — the same classification tier as surgical instruments and diagnostic equipment. Registration confirms the products meet stringent criteria for safe human exposure.
SA DoH Licence number: 549/7826
Class 2a registration in South Africa requires CE Certification as a prerequisite. BEMER Systems carry this internationally recognised certification.
Certified to EU medical device standards.
BEMER Systems carry CE marking pursuant to EU Directive 93/42/EEC for medical devices — functioning as a regulatory passport recognised across the European Union and internationally.
To obtain CE marking, BEMER International AG demonstrated:
Proven medical benefit
Safety for the patient, user, and third parties across the full product lifecycle
Full compliance with all applicable legal and technical requirements
Ongoing post-market surveillance and manufacturer monitoring by the responsible authority
The CE mark affirms the medical quality of BEMER Systems and underpins their regulatory standing in more than 43 countries.
Quality management certified to international standard.
BEMER International AG is DIN EN ISO 13485:2012 certified — the international standard for quality management systems in medical device manufacturing, issued by the German Institute for Standardization (DIN), a member of the International Organisation for Standardization (ISO).
Certification confirms:
The standard is implemented across the entire organisation
All applicable requirements for medical devices are fully met
Extensive quality control including supplier oversight
Proven, optimised processes for assembly, inspection, shipping, and service
Only trained and verifiably qualified personnel are employed
This certification supports and underpins the CE marking for BEMER Systems.