- Intended use is in vitro fertilization
- CE marked according to Medical Devices Directive 93/42/EEC
- Produced and marketed in compliance with the FDA demands for IVF products
- Full batch control of all components in the final product for full traceability
Unique certification based on a 1-cell stage mouse embryo toxicity test; the certificate confirms:
- Sterility (SAL 10-6)
- Non-pyrogenicity
- USP Class VI test