Regulatory & Quality Assurance
AtCor Medical products are included on the Australian Therapeutic Goods Register (ARTG Number: 152313).
The SphygmoCor Cardiovascular Management Suite (CvMS) and SphygmoCor XCEL are CE-marked and approved for import into the European Union.
AtCor Medical’s EU Authorized Representative:
Plato Close, Warwick
The SphygmoCor CvMS and XCEL have received FDA 510k clearance.
The SphygmoCor CvMS and XCEL have received Health Canada approval.
AtCor Medical’s manufacturing plant is based in Sydney, Australia. The facility is certified to ISO 13485 Quality Management Systems for Medical Device Manufacturers and manufactures according to US FDA cGMP requirements.