ELIX medical grades meet the stringent requirements of the Medical Device Industry and include two USP Class VI and ISO 19993 biocompatibility grades, which have registered device and drug master file approvals for use in medical and food-contact applications, both in the European and US markets.
We offer leading solutions for the medical industry with emphasis on regulatory compliance, product safety and a global supply strategy. ELIX counts among our customers with the leading European and US medical injection molders and global pharmaceutical companies.
ELIX medical grades offer many benefits for healthcare applications:
Respiratory devices, Auto Injection devices, Medical HousingVIEW PRODUCT
Infusion SystemVIEW PRODUCT
Food contact applications
Cosmetics packagingVIEW PRODUCT
DMF – Type III
Letter of Authorization
EU, 7 th Edition Chap 3.2.2.
“Plastics Containers and Closures”
JP, 16 Edition, G7
“Plastics Containers for Pharmaceutical Use”
USP Class VI
Up to 30 days human contact duration
Biocompatibility – ISO 10993-1
Biocompatibility Tests for Cytotoxicity, in Vitro Hemocompatibity etc
EU Regulation no. 10/2011
FDA regulation 21CFR
Germany, BfR - Recommendations
REACH compliant products
RoHS 2011/65/EU complaint products
BSE/TSE absence of the risk
Non use of endocrine effective substances
Product Formulations: No-change agreement of up to three years*
Quality Assurance of Raw Materials & Intermediates / Dedicated Quality Management Team:
Sample Storage: Extended sample storage for three years.
Highly Experienced Technical Service:
* In connection with long-term supply agreement.
For inquires please contact our sales team.