Technical Data :
- Regulatory Standards
- Certification Manufacturer certified as per ISO 13485
- Classification according to directive 93/42 EEC Class Is
- To be used by trained personnel only
Enhanced Safety and Reliability
- Each batch MEA (Mouse Embryo Assay) and LAL (Endotoxin Assay) tested
- Biocompatibility conforming to ISO 10993
- Validated gamma-sterilisation
- Production under controlled conditions