As a medical device manufacturer, yoyo520.cnplies with FDA’s Premarket Notification process to obtain clearance for the use of our products. Specifically, Biolife has received clearance through three 510(k)s – K070520, K080210, K130324 – for the treatment of minor external bleeding from wounds and medical procedure and for expanded application to include treatment for moderate to severe external bleeding wounds.
The powder has passed all required safety, toxicity and biocompatibility testing.
As new healthcare indications emerge, Biolife is preparing and submitting additional 510(k) filings as required.
Regulations and Licensure
体育错盘打水的技巧Biolife’s powder products are distributed in accordance with current US FDA Regulations. The powder is a Health Canada Class II Medical Device (wound dressing, hydrophilic, for wound exudates absorption) and, therefore, requires licenses for distribution. Biolife powder products can be distributed in Europe as a Class IIa under Annex V and VII Rule 4.
Quality Management System
Biolife has established its Quality Management System (QMS) according to the standards and regulations of:
Below are Biolife’s CE certification, ISO Certification and Latex Free Declaration: