Certifications

Manufacturing facility:

Onpery Menstrual Cups are manufactured at:

FDA approved clean lab facility.

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.

 

Material:

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

ISO 10993:2018 (Bio-Compatibility Report):
Implantation, Hemolysis Test, Acute Toxicity, Irritation Test, Skin Sensitization, Pyrogenicity, Cytotoxicity & Genotoxity.