Active raw material development - Jiangsu Yaohai Novagen Bio-technology Co.,Ltd.

Raw Materials

Recombinant collagen freeze-dried powder

Medical device grade raw material product display

Key points of core quality control of medical device-grade raw material process

Safety Testing

Test content	Test content by sub-rule	Experimental results	Testing unit
Immunotoxicity test		No adverse effects	Jiangsu Medical Device Inspection Institute
In vitro cytotoxicity		No cytotoxicity	Jiangsu Medical Device Inspection Institute
Delayed hypersensitivity reaction (sensitization)	Skin irritation	No delayed hypersensitivity reaction	Jiangsu Medical Device Inspection Institute
Irritation or intradermal reaction	Intradermal reaction test	No skin irritation	Jiangsu Medical Device Inspection Institute
	Eye irritation test	No intradermal reaction	Jiangsu Medical Device Inspection Institute
	Oral irritation test	No eye irritation reaction	Jiangsu Medical Device Inspection Institute
	Rectal irritation test	No irritation	Jiangsu Medical Device Inspection Institute
	Penis and vaginal irritation test	No irritation	Jiangsu Provincial Medical Device Inspection Institute
	Salmonella typhimurium mutation reversion test (Ames test)	No irritation	Jiangsu Provincial Medical Device Inspection Institute
In vitro genetic toxicity test	Mouse lymphoma cell mutation test	No irritation	Jiangsu Provincial Medical Device Inspection Institute
Acute systemic toxicity test		No irritation	Jiangsu Provincial Medical Device Inspection Institute

Device dressing, injection-grade recombinant collagen raw materials

Instrument dressings, injection grade recombinant collagen raw materials

Heavy metal content