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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