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.
TGA Approved
TGA approved means that a product has been assessed and approved by the Therapeutic Goods Administration (TGA), which is Australia's regulatory authority for medical and therapeutic products. This approval ensures that the product meets strict safety, quality, and efficacy standards before being marketed or sold in Australia.
For medical devices, TGA approval confirms that the product complies with the Medical Device Regulations and is registered on the Australian Register of Therapeutic Goods (ARTG).
International Standards
- IEC 60335-1:2010 + AMD1:2013 + AMD2:2016
- IEC 60335-2-115:2021
Australia & New Zealand Standards
- AS/NZS 60335.1:2020+A1:2021
- AS/NZS 60335.2.115:2021+A1:2022
These certifications ensure our products meet rigorous international safety standards for electrical appliances and beauty care devices.
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.