TOPAS^® 5013L-10 Regulatory Info

TOPAS 5013L-10 is listed in TOPAS Advanced Polymers' Drug Master File (DMF 12132) and Device Master File (MAF 1043) at the US FDA. This grade has passed the following biocompatibility tests:

• Class VI testing (USP and ISO protocols);
• Cytotoxicity (ISO - MEM Elution Test);
• Physicochemical Tests for Plastics (USP);
• Hemolysis (ISO - Rabbit blood).

With this new grade, TOPAS^® again demonstrates a high degree of medical compliance.

US, Canada, Mexico:
Phone:  +1 (859) 746-6447 x4400
eMail:    info@topas.com

Europe & South America:
Phone: +49 (0) 1805-1-TOPAS*
Phone: +49 (0) 1805-1-86727*
eMail:    info@topas.com
0,14€/minute (net provider: T-Com)

Asia:
Polyplastics Co., Ltd.
Phone:  +81-3 6711 8615
eMail: topas.info@polyplastics.com