Medical Certifications

1. Manufactured by our contract manufacturing vendor having a FDA approved clean lab facility with following certifications:
ISO 10993:2018 (Bio-Compatibility Report): Implantation, Hemolysis Test, Acute Toxicity, Irritation Test, Skin Sensitization, Pyrogenicity, Cytotoxicity & Genotoxity
Declarations: RoHS, WEE, Heavy Metal, REACH & TBE/BSE
ISO 13485:2016: Design, Manufacturing and Dispatch of Extruded and Moulded Silicone and FKM Rubber Products in Different Shapes and Sizes used in Medical Industries
ISO 45001:2018, ISO 14001:2015 & ISO 9001:2015: The management system is applicable to Medical Device

2. Material:
- Medical Grade Silicone (USP Class VI) (Silipure Platinum Cure)
- US FDA 21 CFR 177.2600
- Free of Phthalate/Bisphenol/Volatile Plasticizer