德国生物软组织补片(猪心包膜胶原基质)

 

 

 

 

The product is intended for use as a surgical membrane for soft tissue repair, serving as a scaffold material and tissue coverage or tissue replacement for surgical applications where a longer lifetime of the implant after placement is requested.

【Country of origin】

Germany

【properties】

  1. strong and biocompatible implant
  2.  incorporates into the host tissue through cell and microvascular ingrowth
  3. native uncrosslinked membrane with an in-vivo lifetime up to 12 months
  4. high tear-resistance
  5. simple handling

【Applications】

Include:

  1. breast reconstruction
  2. breast and body wall reconstruction
  3. urologic and gynaecological reconstructive surgery of the pelvic floor
  4. reconstructive ENT surgery

【Qualification】

  1. CE Certificate——CE marking signifies that the product conforms with all EC directives that apply to it. When a manufacturer puts the CE marking on a products this implies that he complies to all the Essential Health and safety requirements from all the directives that applies to its product.
  2. ISO10993—— Standards for evaluating the biocompatibility of a medical device. Manufacture strictly tests the biocompatibility  according to ISO10993 standards.
  3. ISO13485——Represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.