Souleir prioritises the health and safety of our customers above all else.
Below are the certifications that our manufactures have attained and are bound by.
MDSAP
Medical Device Single Audit Program - A program that allows a single regulatory audit of a medical device manufacturer to satisfy multiple regulatory requirements. This means our product meets quality standards across multiple countries.
ISO13485
A quality management standard specifically for medical devices. This certification ensures our products are consistently manufactured under strict quality control processes that meet international safety standards.
FDA
Food and Drug Administration - The U.S. government agency responsible for protecting public health by regulating medical devices, drugs, and food products. FDA certification means our product meets U.S. safety standards.
FCC
Federal Communications Commission - A U.S. certification that ensures electronic devices meet standards for electromagnetic interference. This means our device won't interfere with other electronic equipment.
RoHS
Restriction of Hazardous Substances - A certification that confirms our product is manufactured without specific hazardous materials like lead, mercury, and certain flame retardants. This makes our product safer for both you and the environment.
SAA
Standards Association of Australia - An Australian certification mark that indicates our product meets their national safety and quality standards.
Oeko-Tex® Certification
Our products are Oeko-Tex® certified, meaning they are tested for harmful substances and safe for human use.
This globally recognised standard ensures quality, safety, and eco-friendly production practices, giving you peace of mind with every purchase.
CE Conformité Européenne:
A certification mark indicating our product meets the European Union's health, safety, and environmental protection standards. It allows our products to be sold within the European market.
