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
Non-treated
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