Quality and Regulatory

Bentec Medical is ISO 13485, ISO 14644 CLASS 7 CLEANROOM, and FDA Registered.

ISO-13485_2016

State of California Manufacturing License

Health Canada License 80277 OPEN BORDER SILICONE SHEETING

Health Canada License 79769 SILICONE PENROSE DRAIN TUBING

Health Canada License 79770 HELSPER TRACHEOSTOMA VENT

Health Canada License 80278 SILICONE ELASTOMERIC TUBING

Health Canada License 79772 SILICONE VENTRAL WALL DEFECT SILO BAG

Bentec FDA REGISTRATION on www.accessdata.fda.gov